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Discover a more connected career At Dycom Industries, Inc., as a Fiber Splicer, you’ll complete the process of fusing optical fibers, to maintain our telecommunication networks.Your splicing work is essential for keeping strong and reliable connections, ensuring data travels seamlessly through our continually growing network. Connecting you to great benefits Weekly Paychecks Paid Time Off, Parental Leave, and Holidays Insurance (including medical, prescription drug, dental, vision, disability, life insurance) 401(k) w/ Company Match Stock Purchase Plan Education Reimbursement Legal Insurance Discounts on gym memberships, pet insurance, and much more! What you’ll do With guidance, perform cable upgrades and splicing tasks, both aerial and underground Test, activate, and troubleshoot the network’s circuit post-installation Ensure all splicing operations meet strict customer and industry standards Safely navigate working at different heights, from underground to in the air Complete basic daily maintenance of vehicles, including fluid checks Document work performed through daily production reports, including marking up maps and keeping correct material usage records Other duties as assigned What you’ll need To be 18 years of age or older Authorization to work in the United States for this company High School Diploma, GED equivalent, or relevant work experience Valid State driver's license (cannot be considered Provisional), including an acceptable driving record Must be able to pass a DOT physical exam, resulting in a valid medical card 6 months of splicing experience or one year of experience in the telecommunications industry Additional qualifications Certified pole climber or capable of demonstrating proficiency as a pole climber, is preferred Knowledge of telecommunications network structure Physical abilities & exposures Routinely: work at heights, occasional entry into attics and crawl spaces and alone in remote locations, operate vehicle and heavy machinery; squeeze, fine hand motion, bend, stoop, stand, walk, climb stairs, and lift up to 55 pounds without assistance. Occasionally: work in confined spaces, use ladder and gaffs for climbing poles, keyboard and mouse Why grow your career with us Your career here is more than just a job — it's your pathway to opportunity. Our hands-on training, supportive environment, and responsive leadership connect you to work with purpose. Our commitment to you extends beyond professional development to a safety-first culture that ensures you can do what you do best, with peace of mind. Building stronger solutions together Our company is an equal-opportunity employer — we are committed to providing a work environment where everyone can thrive, grow, and feel connected. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Discover a more connected career At Dycom Industries, Inc., as a Fiber Splicer, you’ll complete the process of fusing optical fibers, to maintain our telecommunication networks.Your splicing work is essential for keeping strong and reliable connections, ensuring data travels seamlessly through our continually growing network. Connecting you to great benefits Weekly Paychecks Paid Time Off, Parental Leave, and Holidays Insurance (including medical, prescription drug, dental, vision, disability, life insurance) 401(k) w/ Company Match Stock Purchase Plan Education Reimbursement Legal Insurance Discounts on gym memberships, pet insurance, and much more! What you’ll do With guidance, perform cable upgrades and splicing tasks, both aerial and underground Test, activate, and troubleshoot the network’s circuit post-installation Ensure all splicing operations meet strict customer and industry standards Safely navigate working at different heights, from underground to in the air Complete basic daily maintenance of vehicles, including fluid checks Document work performed through daily production reports, including marking up maps and keeping correct material usage records Other duties as assigned What you’ll need To be 18 years of age or older Authorization to work in the United States for this company High School Diploma, GED equivalent, or relevant work experience Valid State driver's license (cannot be considered Provisional), including an acceptable driving record Must be able to pass a DOT physical exam, resulting in a valid medical card 6 months of splicing experience or one year of experience in the telecommunications industry Additional qualifications Certified pole climber or capable of demonstrating proficiency as a pole climber, is preferred Knowledge of telecommunications network structure Physical abilities & exposures Routinely: work at heights, occasional entry into attics and crawl spaces and alone in remote locations, operate vehicle and heavy machinery; squeeze, fine hand motion, bend, stoop, stand, walk, climb stairs, and lift up to 55 pounds without assistance. Occasionally: work in confined spaces, use ladder and gaffs for climbing poles, keyboard and mouse Why grow your career with us Your career here is more than just a job — it's your pathway to opportunity. Our hands-on training, supportive environment, and responsive leadership connect you to work with purpose. Our commitment to you extends beyond professional development to a safety-first culture that ensures you can do what you do best, with peace of mind. Building stronger solutions together Our company is an equal-opportunity employer — we are committed to providing a work environment where everyone can thrive, grow, and feel connected. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Since 1980, NAI has been a leader in nutritional health, bringing whole food-based supplements to a global population. NAI is a leading expert and manufacturer of dietary supplements, and we are involved in every facet of the industry, including research, development, manufacturing, marketing, and advocacy. As a company, we continue to grow with manufacturing locations in Vista and Carlsbad, CA. We are looking for seasoned and entry level candidates that are interested in working for global company with opportunities for growth, development, competitive pay, and benefits. Summary: The role of the Quality Assurance Specialist is to support the Quality Systems department by assisting in maintaining and improving the quality of products, services and processes within the organization. Responsibilities include ensuring compliance with applicable regulations, supporting quality improvement activities, analyzing data to identify areas for improvement, and collaborating with cross functional teams to investigate root causes and identify improvements to enhance processes and procedures. Experience in dietary supplements, food, pharmaceutical or medical device industries is required. Conducting internal audits, coordinating CAPA and Nonconformance investigations from beginning to end and performing document control functions. Essential Duties & Responsibilities: Preparing and implementing quality assurance policies and procedures. Documenting quality assurance activities and creating audit reports. Maintains complaint and nonconformance processing through records and tracking systems, including root cause analysis and corrective actions. Makes recommendations for improvement by identifying training needs and taking action to ensure companywide compliance. Develops and maintains the FSVP and Supplier Qualification program, policies, and procedures ensuring that program performance and quality conform to established standards, such as: Good Manufacturing Practices, FDA 21 CFR Parts 111 & 117, and FSMA; by actively managing supplier selection, audits, improvement, qualification, and ongoing monitoring in support of existing and new materials and services. Reviews and approves suppliers’ documentation (ex: desktop audits, self-surveys, certifications, 3rd party audit reports). Produces clearly written, accurate, and evidence-based supplier audit reports to management while maintaining detailed documentation. Evaluates supplier performance through evaluation of product performance, supplier questionnaires, and audits to identify opportunities for improvement and confirm required corrective and preventive actions. Performs risk assessments, when required. Recommends actions relating to supplier qualification and disqualification by establishing process and criteria for supplier (including co-manufacturer) qualification, monitoring, and issue resolution. Manages supplier nonconformances and corrective and preventive actions, ensuring plans are developed and executed by suppliers in compliance with the NCR and CAPA processes. Trends and tracks supplier audit findings and performs CAPA follow-up activities through completion. Performs audits and post-audit meetings using generally accepted auditing techniques and tools as well as the team concept, which utilizes effective interpersonal skills. Performs document control activities such as processing change orders from initiation to closure, data entry, and filing. Perform MRP System (BaaN) entries as required. Engage in the electronic Learning Management System (LMS) as an administrator and perform the following activities: Onboarding of new employees in the software management system. Assign/modify employee profiles and job roles. Inactivate/terminate employee profiles in the software. Perform change control activities. Produce various LMS reports as required. Create curriculums and job roles. Assist with troubleshooting and password resets. Responsible for tracking and trending Quality Systems metrics. Performs other responsibilities, in addition to those mentioned above, as assigned by supervisor/manager. Any interpretation or clarification regarding the responsibilities above will be addressed by the supervisor/manager. Qualifications: Knowledge of US FDA cGMP under Title 21 CFR Parts 111 & 117. Knowledge of Standardize Information on Dietary Ingredients (SIDI). Knowledge of Food Safety Modernization Act (FSMA). Knowledge of Foreign Supplier Verification Programs (FSVP). Minimum of 3-5 years auditing experience; CQA certification preferred. Minimum of a Bachelor’s degree in a related technical field or a minimum of 5 years of Quality Assurance Specialist experience in dietary supplement, food, pharmaceutical, or medical device industry required. Required Skills/Work Experience: Deep knowledge of quality assurance terminology, methods and tools. Superb computer skills, including database knowledge. Supplier management experience required. Leadership skills that enable effective interaction with and influence of plant and corporate personnel. Technical knowledge of quality systems; knowledge of relevant government regulations and certification criteria. Excellent verbal and written communication skills; computer and statistical skills. Experience with 3rd party audits and certification programs, such as SGS, NSF, ASI, USP, and TGA. Subject matter expertise in GMPs, HACCP, Allergen Control, ISO, GFSI, FSMA. Ability to identify and resolve problems in a timely manner. Ability and willingness to make decisions. Exhibits sound and accurate judgment. Supports and explains reasoning for decisions. Includes appropriate people in decision-making process. Ability to make decisions in a timely manner. Demonstrates accuracy and thoroughness in day-to-day activities. Looks for ways to improve and promote quality and applies feedback to improve performance. Monitors own work to ensure quality with a right-first-time mentality. Day-to-day functionality requires familiarity with word processing, spreadsheet, database, and electronic document change control systems. Strong organizational skills and ability to multitask and work with minimal supervision. Works well in a team environment and independently. Physical/Mental Requirements: Must have the ability to travel. Must be able to work in an office or production environment. Travel Requirements: Must have the ability and be willing to travel among the company’s local facilities. NAI is an Affirmative Action/Equal Opportunity Employer and will consider all applications without regards to race, sex, age, color, religion, national origin, intersectionality, veteran status, physical or mental disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Upon this conditional offer of employment, a satisfactory completion of a background check (including criminal records check) with submission and passing a pre-employment post offer drug test is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position. Upon successful completion of the background check process, we will determine the date when your employment begins. NAI utilizes E-Verify to electronically verify employment eligibility. Benefits: Medical plan options – Two HMO and one PPO Dental, vision, life insurance and other voluntary benefit options. 3 weeks’ vacation and 11 paid holidays 401K including company matching and profit sharing $1,000 Employee Referral Bonus Quarterly employee lunches, Employee of Month and other recognition programs Opportunities for advancement Comprehensive training Tuition Reimbursement and more! Ability to Commute: Carlsbad, CA 92008 (Required) Work Location: In person Monday through Friday, 8:00 AM to 5:00 PM
Senior Forward Deployed AI Engineer AI Foundry | NewRocket Location: Remote with travel (~25%) Role Overview NewRocket is seeking a highly skilled Senior Forward Deployed AI Engineer to join the AI Foundry team and work directly with customers to deploy, operationalize, and scale AI-powered workflow solutions. This role blends full-stack engineering, enterprise integration, generative AI implementation, and client-facing solution delivery. Forward Deployed AI Engineers partner closely with business consultants, product teams, AI/ML engineers, and customer stakeholders to translate real-world business problems into secure, reliable, deployable AI-driven solutions. As an Anthropic partner/vendor, NewRocket is expanding its capability to design and deliver enterprise solutions using Claude and other leading AI technologies. In this role, you will apply modern LLM engineering practices—including prompt and context engineering, retrieval-augmented generation (RAG), tool use, structured outputs, agentic workflows, model evaluation, and responsible AI controls—to deliver measurable customer value. You will help customers implement agentic AI workflows, intelligent automations, and AI-powered integrations within ServiceNow and broader enterprise ecosystems. You will also contribute directly to the evolution of NewRocket's AI platforms, accelerators, and intellectual property, including the NewRocket Intelligence Platform, Value Realization Dashboard, Data Intelligence Platform, and reusable Agent Packs. This role requires strong engineering skills, curiosity about emerging AI technologies, sound judgment regarding responsible AI deployment, and the ability to operate effectively in fast-moving customer environments. Key Responsibilities Client Delivery & AI Solution Implementation Deploy, configure, and operationalize agentic AI workflows, AI assistants, and AI-powered automations within client ServiceNow environments and enterprise technology ecosystems. Translate customer business requirements, operational processes, and desired outcomes into technical architectures, implementation plans, and production-ready AI solutions. Implement and integrate NewRocket Agent Packs, AI accelerators, and workflow solutions into enterprise environments. Work directly with customer teams to tailor AI solutions to their operating models, business processes, data sources, security requirements, and user needs. Support workshops, discovery sessions, technical working sessions, demonstrations, pilots, and production rollouts. Clearly communicate AI capabilities, limitations, tradeoffs, solution behavior, and adoption considerations to technical and business stakeholders. Anthropic and Generative AI Engineering Build enterprise AI applications and workflows using Claude, the Anthropic API, and other LLM platforms as appropriate for the client use case. Apply effective prompt and context-engineering techniques, including clear instructions, examples, role and task definition, structured inputs, response constraints, and long-context management. Design and implement AI workflows using structured outputs, tool use/function calling, API integrations, multi-step orchestration, and human-in-the-loop review patterns. Build retrieval-augmented generation (RAG) solutions that ground AI responses in authorized enterprise data and knowledge sources. Implement practical techniques to improve reliability and user trust, including citation or source-grounding patterns, validation, confidence thresholds, output schemas, fallback handling, and escalation workflows. Stay current on Anthropic platform capabilities, Claude model releases, implementation guidance, responsible AI principles, and enterprise deployment best practices. Complete relevant Anthropic training, partner enablement, and technical education programs as available, and incorporate those practices into NewRocket solution delivery. Solution Engineering & Prototyping Build demos, prototypes, and proof-of-concept implementations that validate AI-driven workflows and customer use cases. Rapidly iterate with customers and internal teams to refine AI-powered solutions based on feedback, performance results, and operational needs. Support the design and implementation of AI orchestration, LLM integrations, agentic decision models, and workflow automation patterns. Evaluate when an agentic approach is appropriate versus deterministic automation, traditional workflow logic, search, analytics, or human review. Develop reusable implementation patterns, solution templates, prompt libraries, integrations, and deployment assets that accelerate future client delivery. Full-Stack Engineering & Integration Develop secure integrations between ServiceNow, enterprise systems, APIs, data platforms, and AI services. Build supporting components such as scripts, microservices, automation logic, integration services, and lightweight user interfaces. Implement integrations with AI platforms, enterprise APIs, identity systems, document repositories, databases, and structured and unstructured data sources. Apply sound engineering practices for authentication, authorization, secrets management, access controls, logging, error handling, version control, and documentation. Design solutions that meet enterprise expectations for security, scalability, maintainability, observability, and production readiness. AI Quality, Evaluation & Responsible AI Develop and execute practical evaluation approaches for AI applications, including test cases, representative datasets, success metrics, and regression testing. Assess AI workflow quality across dimensions such as relevance, accuracy, groundedness, task completion, safety, latency, cost, and user experience. Implement safeguards for sensitive data, role-based permissions, appropriate data access, prompt injection risks, unsafe tool use, and unintended model behavior. Establish human-in-the-loop workflows for sensitive, high-impact, low-confidence, or exception-based decisions. Document AI solution behavior, known limitations, risk controls, governance considerations, and operational support procedures. Monitor and improve deployed solutions based on user feedback, usage patterns, performance data, incidents, and evolving customer needs. Product & Platform Contribution Actively contribute to the development and evolution of NewRocket's AI intellectual property and platforms, including: NewRocket Intelligence Platform Value Realization Dashboard Data Intelligence Platform Agent Packs and reusable AI solution accelerators Responsibilities include: Identifying common patterns, requirements, integration needs, and capabilities discovered through customer deployments. Contributing reusable assets, integration components, prompt patterns, evaluation frameworks, and automation capabilities. Providing actionable product feedback that improves usability, reliability, scalability, security, and customer value. Helping transform successful client implementations into repeatable platform features, accelerators, and delivery playbooks. Supporting the definition of standards and best practices for enterprise AI delivery across NewRocket's AI Foundry. Systems Integration & Troubleshooting Diagnose and resolve technical issues across AI workflows, integrations, retrieval pipelines, data connections, and automation processes. Troubleshoot issues related to model inputs and outputs, prompt behavior, tool execution, API reliability, permissions, data quality, and system performance. Ensure deployed AI solutions are secure, scalable, supportable, and production-ready. Optimize deployed systems for reliability, performance, latency, model usage, and cost efficiency. Cross-Team Collaboration Work closely with Business Process Consultants, Product Engineering, Data Engineers, AI/ML Engineers, ServiceNow teams, and the AI Center of Excellence. Serve as the engineering counterpart to consulting and delivery teams throughout discovery, solution design, implementation, rollout, and continuous improvement. Contribute to internal playbooks, technical documentation, reusable deployment patterns, reference architectures, and product evolution. Share lessons learned from customer deployments to strengthen NewRocket's AI delivery capabilities and solution portfolio. What Success Looks Like in the First 6 Months Successfully deploy AI-powered workflows, assistants, automations, or integrations across multiple customer engagements. Deliver secure, reliable AI workflows within customer ServiceNow environments and connected enterprise systems. Build trusted relationships with customer technical teams, business stakeholders, and NewRocket delivery teams. Demonstrate strong practical application of Claude and modern LLM engineering practices, including prompt/context engineering, tool use, RAG, evaluations, and responsible AI controls. Contribute reusable components, implementation patterns, prompt assets, and improvements to NewRocket's AI platforms and accelerators. Provide actionable customer-driven feedback that improves the NewRocket Intelligence Platform and related products. Help establish repeatable methods for moving AI use cases from prototype through governed production deployment. Required Qualifications 8+ years of experience in software engineering, systems integration, enterprise platforms, workflow automation, or related technical delivery roles. Strong engineering foundation, with hands-on experience in full-stack development, scripting, APIs, microservices, enterprise integrations, or cloud-native applications. Experience building, deploying, or supporting AI/LLM-powered applications, AI-enabled automations, conversational experiences, RAG systems, or agentic workflows. Experience integrating APIs, enterprise applications, data platforms, or workflow systems in production environments. Proficiency in JavaScript/TypeScript, Python, or similar programming and scripting languages. Experience with cloud platforms such as AWS, Microsoft Azure, or Google Cloud. Familiarity with modern LLM application concepts, including prompt engineering, context windows, token usage, embeddings, vector search, RAG, tool use/function calling, structured outputs, and model evaluation. Understanding of responsible AI concepts, including hallucination mitigation, sensitive-data handling, identity and access controls, human oversight, AI safety, and secure AI deployment. Experience operating in customer-facing engineering, consulting, technical implementation, solutions architecture, or professional-services roles. Strong problem-solving skills and the ability to communicate complex technical concepts clearly to both technical and business stakeholders. Ability to manage ambiguity, prioritize effectively, travel approximately 25%, and deliver high-quality solutions in fast-moving customer environments. Preferred Qualifications Anthropic / Claude Experience Hands-on experience with the Anthropic API, Claude models, Anthropic Console, Claude Code, or Anthropic implementation guidance. Completion of relevant Anthropic Academy learning, partner enablement, technical training, or equivalent hands-on experience deploying Claude-based solutions. Experience applying Claude capabilities such as long-context processing, tool use, structured outputs, document analysis, and enterprise knowledge workflows. Familiarity with Model Context Protocol (MCP) concepts and experience building or integrating secure tools and data connections for AI applications. ServiceNow Experience — Strong Plus Experience with ServiceNow development, configuration, workflow automation, or enterprise platform implementation. Familiarity with ServiceNow scripting, APIs, IntegrationHub, Flow Designer, Virtual Agent, Now Assist, AI Agents, and platform development patterns. Understanding of ServiceNow data models and enterprise workflow concepts, including: CMDB ITSM, CSM, HRSD, or employee workflows Workflow and task tables Knowledge management Enterprise integrations and data exchange patterns AI, Data & Platform Experience Experience building AI prototypes, RAG systems, semantic search capabilities, AI assistants, or agent-based workflows. Experience integrating LLM APIs or AI services into enterprise applications and business processes. Experience with vector databases, embeddings, document ingestion, chunking, retrieval strategies, and knowledge-grounding patterns. Familiarity with LLM orchestration and application frameworks such as LangChain, LangGraph, LlamaIndex, Semantic Kernel, or comparable tools. Experience with AI observability, tracing, evaluation frameworks, prompt/version management, monitoring, and cost optimization. Experience contributing to internal platforms, reusable accelerators, developer tooling, or product capabilities. Familiarity with Docker, CI/CD, SQL, Git, infrastructure-as-code, and secure cloud deployment practices. Why This Role Matters Forward Deployed AI Engineers are the bridge between real-world enterprise problems and NewRocket's AI platforms. By working directly with customers, they deliver immediate operational value while shaping the evolution of NewRocket's AI products, accelerators, and platform capabilities. This role is critical to scaling the NewRocket Intelligence Platform and the broader AI Foundry strategy. As NewRocket expands its partnership with Anthropic, this engineer will help establish practical, secure, and responsible patterns for deploying Claude-powered AI solutions that improve enterprise workflows, accelerate decision-making, and create measurable business outcomes. We Take Care of Our People NewRocket is committed to a diverse and inclusive workplace. We value and celebrate diversity, believing that every employee matters and should be respected and heard. We are proud to be an equal opportunity workplace and affirmative action employer, committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin, or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, citizenship, military, or Veteran status. For individuals with disabilities who would like to request an accommodation, please contact [email protected].
Position Summary Vanguard Solutions is seeking an experienced Quality Engineer to support a medical device manufacturing organization with a primary focus on Test Method Validation (TMV). This is a six (6) month minimum contract. The consultant will assess existing manufacturing inspection and test methods that have not previously been validated, evaluate those methods against current Quality System procedures and Test Method Validation requirements, identify compliance or technical gaps, and develop an appropriate validation strategy. The engineer will then be responsible for authoring, executing, analyzing, and documenting attribute and variable Test Method Validations, including Measurement System Analysis (MSA), Gage R&R, and Attribute Agreement studies as applicable. The role may also support CAPA and Nonconformance (NCR) activities as needed. This is a hands-on individual-contributor position requiring close collaboration with Quality, Manufacturing Engineering, inspectors/operators, and other cross-functional stakeholders. Primary Responsibilities * Review existing manufacturing test and inspection methods that have not been formally validated. * Assess each test method against current internal SOPs, procedures, acceptance criteria, and Quality System requirements. * Perform a documented gap assessment to determine whether the existing method is adequately defined and suitable for validation. * Review test-method instructions for clarity, objectivity, repeatability, equipment requirements, operator technique, sample preparation, and acceptance criteria. * Determine whether methods require attribute or variable Test Method Validation. * Develop an appropriate TMV strategy based on the type of measurement, method risk, intended use, and applicable procedural requirements. * Author TMV protocols, including study design, sample selection, appraisers/operators, repetitions, acceptance criteria, statistical methods, and predefined requirements. * Execute or coordinate execution of TMV studies with operators, inspectors, Quality, and Manufacturing Engineering. * Perform variable Measurement System Analysis / Gage R&R studies. * Perform attribute Test Method Validation / Attribute Agreement Analysis. * Evaluate repeatability, reproducibility, operator/appraiser variation, equipment variation, and method variation. * Evaluate attribute-method performance including false acceptance, false rejection, within-appraiser agreement, and between-appraiser agreement, as applicable. * Analyze TMV results using appropriate statistical techniques and software such as Minitab. * Investigate unacceptable or marginal TMV results and determine whether deficiencies originate from the method, equipment/fixture, operator technique, sample selection, acceptance criteria, or inherent product variation. * Recommend and implement improvements to inspection/test procedures when a method is not suitable for validation. * Update or support updates to test methods, inspection procedures, work instructions, and related controlled documentation. * Author final TMV reports documenting study execution, statistical analysis, deviations, conclusions, and validation status. * Ensure TMV documentation complies with applicable internal procedures and medical-device Quality System requirements. * Maintain traceability between the test method, applicable requirements/specifications, validation protocol, results, and final report. * Support CAPA, NCR, and root-cause investigations as required. * Participate in nonconformance investigations, product-impact assessments, containment activities, dispositions, and corrective actions when needed. * Collaborate closely with Quality Engineering, Manufacturing Engineering, Operations, R&D, and inspection personnel. Required Qualifications * Bachelor’s degree in Engineering, Science, Quality, or a related technical discipline. * Experience working in a medical-device or similarly regulated manufacturing environment. * Demonstrated hands-on experience with Test Method Validation. * Experience independently reviewing an existing test or inspection method and determining whether it is suitable for validation. * Experience developing TMV protocols and reports, not solely reviewing or approving documentation prepared by others. * Hands-on experience with variable Gage R&R / Measurement System Analysis. * Hands-on experience with attribute Test Method Validation / Attribute Agreement Analysis. * Working knowledge of repeatability and reproducibility concepts. * Experience establishing appropriate sample sizes, operators/appraisers, repetitions, and acceptance criteria for TMV studies. * Ability to interpret and troubleshoot failed or marginal TMV results. * Experience using Minitab or equivalent statistical software. * Strong technical-writing skills. * Working knowledge of ISO 13485, FDA Quality System requirements, and risk-based Quality Engineering principles. * Experience with root-cause analysis and structured problem-solving techniques. Preferred Qualifications * Experience validating inspection methods used in catheter, guidewire, balloon, delivery-system, or other minimally invasive medical-device manufacturing. * Experience with dimensional inspection, visual inspection, tensile testing, leak/burst testing, bond-strength testing, or similar medical-device test methods. * Experience with CMM, optical measurement systems, tensile testers, force gauges, microscopes, calipers, micrometers, or other inspection equipment. * Experience with CAPA and NCR investigations. * Experience with PFMEA/FMEA and ISO 14971 risk-management principles. * Experience working directly with manufacturing operators and inspectors to improve inspection/test methods. Key Deliverables * Inventory/review of assigned unvalidated test methods * Assessment of each method against the current TMV SOP/procedure * Documented gap assessment and recommended remediation * Updated test/inspection methods where required * Attribute or variable TMV protocols * Execution of TMV studies * Statistical analysis of study results * Investigation/remediation of failed or marginal methods * Final TMV reports and validation conclusions * Supporting CAPA/NCR documentation where applicable Pay: $60.00 - $70.00 per hour Expected hours: No more than 40.0 per week Application Question(s): * Do you have hands-on experience performing Test Method Validation (TMV) in a medical device or similarly regulated manufacturing environment? * Have you personally authored and executed both attribute and variable Test Method Validation protocols? * Have you used Minitab or equivalent statistical software to analyze TMV, Gage R&R, MSA, or attribute agreement studies? * Do you have experience supporting CAPA and Nonconformance (NCR) investigations in a regulated manufacturing environment? * Do you have experience working with medical devices such as catheters, guidewires, balloons, delivery systems, or other minimally invasive devices? * Are you available to work full-time onsite in Carlsbad, California through February,2027? * Are you legally authorized to work in the United States without requiring current or future employer sponsorship? Work Location: In person
We at Champion Metal Works are an established and respected Metalworks Company seeking a skilled Traveling Iron Worker Welder/Fabricator to take on an essential, traveling role throughout California. The selected candidate will perform high-quality ironwork and fabrication on active construction sites while maintaining strong organization, clear communication, and reliable time management. We are looking for someone to be an innovative collaborator with a passion to succeed, who will be adaptable, versatile, willing to learn, and wants to grow with the company! If you have a “Team First” mentality, this is the job for you! See below for a more in-depth listing of responsibilities. POSITION SUMMARY The Traveling Ironworker Welder/Fabricator is responsible for supporting field erection and shop fabrication, with the majority of work performed on multi‑week travel assignments at project sites. This role requires working overnight shifts while completing certified structural welding, assisting with steel erection, and contributing to fabrication projects from start to finish. Candidates must have 3–5 years of ironwork experience, welding proficiency with 232 certifications, and the physical ability to perform demanding tasks in both shop and field environments. Success in this position requires full availability for extended travel, comfortable with an overnight work schedule, and the adaptability to operate in varying jobsite conditions. KEY RESPONSIBILITIES Include but are not limited to: Assist Field Foreman with jobsite preparation and erection activities on job sites. Perform structural welding. Load and unload materials and tools to support daily operations. Able to work out of town for up to 2 weeks at a time When you are not in the field, there will be fabrication and general work in the shop Assist with fabrication projects in the shop and field. Operate machinery, hand tools, and welders safely and effectively. Ensure tools are properly stored after use. Maintain a clean and organized job area. Support adherence to safety protocols and procedures. QUALIFICATION 3-5 years' iron work experience 232 structural welding certification and welding proficiency required OSHA 10 certificate, preferred Machinery operations certificate, preferred Ability to assist with field erection and jobsite preparation Experience with fabrication work in both shop and field setting Skilled in operating welders, machinery, and hand tools safely Willingness to travel and work out of town for extended periods Willingness to work all overnight shifts Ability to lift up to 50 lbs. and stand for extended periods. BENEFITS Medical Dental Vision 401k Per Diem *This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this position. Duties, responsibilities and activities may change at any time with or without notice based on the needs of the department and company. To perform this job successfully, the perfect candidate will possess a proficient level of the knowledge, skills and abilities listed within this description. Please note, this document does not create an employment contract, implied or otherwise with the company.
Position Summary/ Objective: Under the direction of the Front Desk Manager and/or Director, the Front Desk Supervisor will be responsible for supervising the front desk operation of the resort, assisting with training of associates, providing guest and/or owner satisfaction, and maximizing revenue and occupancy in accordance with GPR standards. Associate will work independently or in a team under little to no supervision. This position relies on excellent judgment to perform the functions of the job. Primary Essential Functions: All associates are obligated to support and uphold the values, expectations, policies, and procedures of Grand Pacific Resorts as outlined in the Employee Handbook. Observe associates while they work to ensure proper owner/guest checking in and out of resort in a courteous, efficient and professional manner. Account for guest room inventory, cash handling, and other administrative responsibilities per policies and procedures. Perform front desk duties as necessary such as registration, check out and processing reservations for guests. Communicate closely with Housekeeping and Maintenance regarding discrepancies and quality of rooms division. Respond to and resolve guest requests and concerns in a timely and professional manner, and escalate matters to the Front Desk Manager and/or Director when applicable. Remain knowledgeable of hotel services and facilities, special promotions, daily activities, groups in house, and special requests. Maintain the enforcement of guidelines regarding health and safety policies and procedures. Remain knowledgeable of emergency procedures, current projects, reports on any damages or repairs needed. Exemplify the proper appearance of uniform and nametag usage. Assist with any additional tasks or special projects as assigned by the Front Desk Manager and/or Director. Responsible for conducting all responsibilities in a professional and ethical manner. Responsible for maintaining a consistent, regular attendance record. Adhere to performance standards, company policies and procedures, as they relate to the department. Education, Skills & Experience: The ideal candidate must be a detail oriented, thorough, and professional individual who consistently provides exemplary customer service to guests, owners, management and associates. At least one year of experience in a guest facing front office capacity. At least 6 months of supervisory/management experience, rooms management experience preferred. A degree or diploma in Hospitality Management or an equivalent combination of education and experience preferred. Customer- service focused, results driven, problem solving skills. Professional communication skills with guests, supervisors and associates. Ability to multi-task with a sense of urgency without compromising quality. Proficient in reading, writing, math, and computer (Microsoft Word, Excel) skills. Capable of providing on the job training. Experience in the hospitality industry (time share preferred). Ability to work well in a diverse team environment. Additional Eligibility Qualifications Required: Must be available to work various shifts including weekends and holidays. Must be able to successfully pass applicable auditions or skill testing, background check, physical examination and drug screening test. Ability to speak and understand the English language. Physical, Environmental & Other Requirements: Must be able to stand and/or walk for up to 8 hours. Must also be able to sit, stoop, kneel, crouch and crawl. Must frequently lift and/or move up to 10 pounds and occasionally required to lift and/or move up to 25 pounds. Clear vision (close, distant and depth perception) is needed for navigating office and all other buildings within the resort. EEO Statement: Grand Pacific Resorts provides equal employment opportunities (EEO) to all associates and applicants for all terms and conditions of employment, in every location in which the company has facilities, regardless of any basis protected by applicable federal, state or local law. Other Duties: Please note that this job description does not list all the duties of the job. You may be instructed by upper management to perform other tasks or functions. You will be evaluated in part based upon your performance of the tasks listed in this job description and your ability to commit to the Standards of Excellence. Management has the right to revise this job description at any time. The job description is not a contract for employment.
POSITION PURPOSE Clean guest rooms in accordance with established quality and performance standards to allow a sufficient quantity of vacant and clean guest rooms for sale. Self-Inspect clean guest rooms for sale. Clean occupied guest rooms. ESSENTIAL FUNCTIONS Clean and reset guest bedroom and bathroom areas according to established standards as follows: Sort, count, fold and carry linen Make beds Replenish supplies, i.e., amenities, drinking glasses, clean linen Lift and move furniture weighing no more than 20 lbs Sweep, scrub bathroom floor using broom and mops Clean rugs, carpets, upholstered furniture using vacuum cleaner and or proper chemicals Dusts furniture, equipment and fixtures Washes tile walls, tub, sink and toilets Polishes woodwork and metal work such as fixtures and metal fittings Cleans windows, door panels and sills Empties wastebaskets Replenishes bathroom supplies Organize and stock cleaning cart and organize linen closets on floors assigned. Complete accurately, and in a timely manner, any assigned paperwork. Clean hallway, restrooms, elevators, stairwells, locker rooms and other work areas All other duties as assigned by a manager or supervisor SUPPORTIVE FUNCTIONS In addition to performance of the essential functions, this position may be required to perform a combination of the following supportive functions, with the percentage of time performing each function to be solely determined by the manager based upon the particular requirements of the hotel: Perform general cleaning tasks using standard hotel cleaning products to adhere to health standards. Perform other duties as requested, such as cleaning unexpected spills and executing special guest requests. Assist other housekeeping employees in maintaining clean and organized work area. Maintain at all times a neat and clean professional appearance Enforce hotel safety standards. Perform other duties and handle projects as assigned by Manager. Follow all of the Safety and Sanitation Guidelines set forth by the CDC and GPR including but not limited to all of the COVID-19 State and County ordinances Must be able to work flexible schedules including weekends and holidays SPECIFIC JOB KNOWLEDGE, SKILLS AND ABILITIES The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation, using some other combination of knowledge, skills, and abilities: Must be able to speak, read, write and understand the primary language(s) used in the workplace. Must be able to read and write to facilitate the communication process. Requires good communication skills, both verbal and written. Knowledgeable with carpet care and floor care Some experience with carpet and floor care equipment preferred Knowledgeable with cleaning chemicals and supply equipment Physical Demands Work tasks are performed indoors and outdoors. Temperature is moderate and controlled by hotel environmental systems. Must be able to stand and exert well-paced mobility for up to 4 hours in length. Must be able to exert well-paced ability to maneuver between functions occurring simultaneously. Must be able to exert well-paced ability in limited space and to reach other departments of the hotel on a timely basis. Must be able to bend, squat and lift up to 75 lbs. on a regular and continuing basis. Must be able to push and pull carts and equipment weighing up to 250 lbs. on a regular and continuing basis. Must be able to bend, stoop, squat and stretch to fulfill cleaning tasks. Requires grasping, writing, standing, sitting, walking, repetitive motions, bending, climbing, listening and hearing ability and visual acuity. Talking and hearing occur continuously in the process of communicating with guests, supervisors and other employees. Vision occurs continuously with the most common visual functions being those of near vision and depth perception. Requires manual dexterity to use and operate all necessary equipment. QUALIFICATION STANDARDS Education High school or equivalent education required. Experience Prior commercial housekeeping experience required. Prior hospitality experience preferred. Supervisory experience preferred. Licenses or Certificates Drivers License desired Attendance: Regular attendance in conformance with the standards, which may be established by Westin/Sheraton Carlsbad Resort & Spa from time to time, is essential to the successful performance of this position. Employees with irregular attendance / tardies will be subject to disciplinary action, up to and including termination of employment. Upon employment, all employees are required to fully comply with Westin/Sheraton Carlsbad Resort & Spa rules and regulations, non-compliance will be subject to disciplinary action, up to and including termination of employment. This job description is not an exclusive or exhaustive list of all job functions that an employee in this position may be asked to perform from time to time. This job opportunity for employment is being made available by Grand Pacific Hotel Services, L.P., the owner and the employer of all associates working at Westin/Sheraton Carlsbad Resort & Spa. Marriott International is not the owner or operator of Westin/Sheraton Carlsbad Resort & Spa. Marriott International is not the direct or indirect employer or joint employer of any associates working at Westin/Sheraton Carlsbad Resort & Spa. Marriott International does not control, govern or regulate any aspect of recruitment or employment at Westin/Sheraton Carlsbad Resort & Spa. Marriott International is not responsible for any aspect of your application, candidacy, or employment at the resort, nor shall Marriott International be liable for the data collection, use and privacy practices of the Westin/Sheraton Carlsbad Resort & Spas owner or operator. ACKNOWLEDGEMENT I have carefully read and understand the contents of this job description. I understand the responsibilities, requirements and duties expected of me. I understand that this is not necessarily an exhaustive list of responsibilities, skills, duties, requirements, efforts or working conditions associated with the job. While this list is intended to be an accurate reflection of the current job, Grand Pacific Hotel Services, L.P. reserves the right to revise the functions and duties of the job or to require that additional or different tasks be performed as directed by the Westin/Sheraton Carlsbad Resort & Spa. I understand that I may be required to work overtime, different shifts or hours outside the normally defined workday or workweek. I also understand that this job description does not constitute a contract of employment nor alter my status as an at-will associate. I have the right to terminate my employment at any time, with or without cause and with or without advance notice, and Westin/Sheraton Carlsbad Resort & Spa has a similar right. Nothing in this Handbook will limit the right to terminate at-will employment. No manager, supervisor or other associate of the Company has any authority to enter into an agreement for employment for any specified period of time or to make an agreement for employment other than at-will terms. Only the Co-Presidents of the Company have the authority to make any such agreement which must be in writing.
POSITION PURPOSE Provide a warm welcome and farewell experience for arriving and departing guests while overseeing valet and bell service standards. Assist guests with luggage, vehicle handling, directions, and property information, while supporting the valet and bell team through training, communication, brand standards awareness, and operational coordination to ensure efficient, safe, and guest-focused service. ESSENTIAL FUNCTIONS Greet all arriving and departing guests. Offer directions to conference attendees. Maintain standards of excellence in the escorting of guests to and from their rooms and assist with luggage. Inform guests of all accommodation features, property amenities, and promote hotel outlets. Safely operate all guest vehicles when parking and pulling vehicles on hotel property, including standard and automatic transmission vehicles as required. Obey all California traffic laws while operating vehicles. Ensure valet and bell team members adhere to established service standards, brand standards, and departmental operating procedures. Communicate site inspection needs and deliver on-site inspection support in coordination with hotel leadership and appropriate departments. Attend group resume meetings as assigned and communicate relevant group details, arrival patterns, service expectations, and operational updates to the valet and bell team. Manage valet lot usage based on business needs, including expanding or reducing designated valet parking areas as occupancy, events, and operational volume require. Train new valet and bell staff on guest service expectations, safety procedures, property standards, vehicle handling, luggage handling, and departmental processes. Support the development and communication of incentives or contests designed to improve team performance, guest service, productivity, and engagement. Maintain accurate shuttle and vehicle logs. Promote Brand Loyalty Program to guests upon arrival and recognize club members. Supervise luggage retrieval and ensure accuracy. Store guest baggage upon request and assist with the loading and unloading of baggage into and out of automobiles. Summon taxis upon request. Shuttle guests to Legoland and within five miles of the resort. Assist guests with boxes to conference center and all other requests that are considered services that promote the hotel in a guest’s perception but do not conflict with Hotel or Departmental standard operating procedures or are governed by state and federal laws. Complete tasks for the day including the maintenance and cleanliness of Valet Stand, Driveway and surrounding areas, Bell closet, Bell cart, Luggage Cart, Front Drive, and Lobby windows. Setup and refreshing of Lobby water and maintain lobby in its cleanliness and organization. Ensure uniforms are clean and pressed. Maintain stocks of supplies needed for department and order appropriately always keeping within budgeted amounts. Ensure parking signage for Twenty/20 Grill is displayed as scheduled. Attend all scheduled training, departmental and hotel meetings and activities, refer all questions or concerns to immediate supervisor or departmental manager, promote positive working environment for all associates, and follow all guidelines and procedures set forth in employee handbook. Other: Regular attendance in conformance with the standards, which may be established from time to time, is essential to the successful performance of this position. Employees with irregular attendance will be subject to disciplinary action, up to and including termination of employment. Due to the cyclical nature of the hospitality industry, employees may be required to work varying schedules to reflect the business needs of the hotel. In addition, attendance at all scheduled training sessions and meetings is required. Upon employment, all employees are required to fully comply with Westin/Solea Carlsbad Resort & Spa rules and regulations for the safe and effective operation of the hotel’s facilities. Employees who violate hotel rules and regulations will be subject to disciplinary action, up to and including termination of employment. SUPPORTIVE FUNCTIONS In addition to performance of the essential functions, this position may be required to perform a combination of the following supportive functions, with the percentage of time performing each function to be solely determined by the manager based upon the particular requirements of the hotel: Ascertain that all doors including rear doors are properly secured. Recommend to guests that all valuables be secured in trunk or safety deposit boxes provided at the front desk. Assist incoming and outgoing guests with getting baggage out of and into vehicles as requested. Assist with communicating daily operational updates, group information, and service reminders to valet and bell team members. Support ongoing team awareness of brand standards, service expectations, and guest arrival and departure needs. SPECIFIC JOB KNOWLEDGE, SKILLS AND ABILITIES The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation, using some other combination of knowledge, skills, and abilities: Must be able to speak and understand the primary language(s) used in the workplace. Requires good verbal communication skills. Must have satisfactory driving record. The Company’s Driver’s Insurance requirements must be met, including: I. In order for a driver to be approved, the following criteria must be met: Maximum of 1 moving violation in the last three years in combination with one at fault 1 accident. Maximum of 2 moving violations in the last 3 years with no at fault accidents. Maximum of 2 at fault accidents in the last 3 years with no moving violations. No speeding over 80 miles per hour. All drivers must be licensed for at least 3 years. II. Any driver with any of the following in the last 3 years is unacceptable: Conviction for an alcohol and/or drug related driving offense Refusal to submit to a Blood Alcohol Content (BAC) Test Failure to stop/report an accident and leaving the scene of an accident as defined by State laws Conviction for homicide, manslaughter, or assault arising out of the use of a vehicle Suspension, revocation, or administrative restriction of driver’s license within the last three years Conviction for reckless or careless driving Racing Passing a stopped school bus Possession of a controlled substance Making a false accident report Three or more “Company Vehicle” physical damage claims in any twelve month period Speeding (10+MPH over posted speed limit) Conviction for attempting to elude a police officer. III. As respects to Drivers under 25 years old, the following guidelines apply: No drivers under 21 years’ old Drivers between the ages of 21 and 25 will be considered so long as: No driving of 15 passenger vans. Clean MVR Valid Driver’s License in effect for at least 3 years. Physical Demands Most work tasks are performed outdoors. There is no effective protection from weather. The worker is driving and getting in and out of vehicles most of the day. Must be able to stand or drive and exert well-paced mobility for up to 4 hours in length. Must be able to lift up to 60 lbs. on a regular and continuing basis. Must be able to push and pull carts and equipment weighing up to 250 lbs. frequently. Must be able to bend, stoop, squat and stretch to fulfill cleaning and luggage handling tasks. Requires grasping, writing, standing, sitting, walking, repetitive motions, bending, climbing, listening and hearing ability and visual acuity. Talking and hearing occur continuously in the process of communicating with guests, supervisors and other employees. Vision occurs continuously with the most common visual functions being those of near and color vision and depth perception. Requires manual dexterity to use and operate all necessary equipment. Physical Demands Most work tasks are performed outdoors. There is no effective protection from weather. The worker is driving and getting in and out of vehicles most of the day. Must be able to stand or drive and exert well-paced mobility for up to 4 hours in length. Must be able to lift up to 60 lbs. on a regular and continuing basis. Must be able to push and pull carts and equipment weighing up to 250 lbs. frequently. Must be able to bend, stoop, squat and stretch to fulfill cleaning and luggage handling tasks. Requires grasping, writing, standing, sitting, walking, repetitive motions, bending, climbing, listening and hearing ability and visual acuity. Talking and hearing occur continuously in the process of communicating with guests, supervisors and other employees. Vision occurs continuously with the most common visual functions being those of near and color vision and depth perception. Requires manual dexterity to use and operate all necessary equipment. QUALIFICATION STANDARDS Education & Experience 2-4 Years Prior Hotel Guest Services Experience Prior bell and/or valet experience required. Clean Driving Record Ability to operate all types of passenger vehicles (standard and automatic). Ability to operate stick shift/manual transmission vehicles. High School completion OR an equivalent level of education and experience. A minimum of 21 years of age Licenses or Certificates Not applicable Grooming All employees must maintain a neat, clean and well-groomed appearance per Westin/Solea Carlsbad’s standards. Attendance: Regular attendance in conformance with the standards, which may be established by Westin/Solea Carlsbad Resort & Spa from time to time, is essential to the successful performance of this position. Employees with irregular attendance / tardies will be subject to disciplinary action, up to and including termination of employment. Upon employment, all employees are required to fully comply with Westin/Solea Carlsbad Resort & Spa rules and regulations will be subject to disciplinary action, up to and including termination of employment. This job description is not an exclusive or exhaustive list of all job functions that an employee in this position may be asked to perform from time to time. Ownership: This job opportunity for employment is being made available by Grand Pacific Hotel Services, L.P., the owner and the employer of all associates working at Westin/Solea Carlsbad Resort & Spa. Marriott International is not the owner or operator of Westin/Solea Carlsbad Resort & Spa. Marriott International is not the direct or indirect employer or joint employer of any associates working at Westin/Solea Carlsbad Resort & Spa. Marriott International does not control, govern or regulate any aspect of recruitment or employment at Westin/Solea Carlsbad Resort & Spa. Marriott International is not responsible for any aspect of your application, candidacy, or employment at the resort, nor shall Marriott International be liable for the data collection, use and privacy practices of the Westin/Solea Carlsbad Resort & Spa’s owner or operator. ACKNOWLEDGEMENT I have carefully read and understand the contents of this job description. I understand the responsibilities, requirements and duties expected of me. I understand that this is not necessarily an exhaustive list of responsibilities, skills, duties, requirements, efforts or working conditions associated with the job. While this list is intended to be an accurate reflection of the current job, Grand Pacific Hotel Services, L.P. reserves the right to revise the functions and duties of the job or to require that additional or different tasks be performed as directed by the Westin/Solea Carlsbad Resort & Spa. I understand that I may be required to work overtime, different shifts or hours outside the normally defined workday or workweek. I also understand that this job description does not constitute a contract of employment nor alter my status as an at-will associate. I have the right to terminate my employment at any time, with or without cause and with or without advance notice, and Westin/Solea Carlsbad Resort & Spa has a similar right. Nothing in this Handbook will limit the right to terminate at-will employment. No manager, supervisor or other associate of the Company has any authority to enter into an agreement for employment for any specified period of time or to make an agreement for employment other than at-will terms. Only the Co-Presidents of the Company have the authority to make any such agreement which must be in writing. Associates Signature: Date: Supervisor’s Signature: Date:
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! MANAGER/ SENIOR MANAGER, GMP QUALITY - DRUG SUBSTANCE SUMMARY: Ionis is seeking an experienced Manager/Senior Manager, GMP Quality - Drug Substance to provide Quality Assurance activities supporting both clinical and commercial Drug Substance (DS) manufacturing and testing. This role provides strategic leadership, operational oversight, and hands-on QA expertise across internal operations and external manufacturing partners. WORK LOCATION: Onsite in Carlsbad, CA CORE RESPONSIBILITIES: Lead and manage GMP Quality Assurance activities supporting internal and external Drug Substance and Intermediate manufacturing, testing, and release. Senior Manager: May manage, mentor, and develop QA staff and/or provide functional leadership to matrixed teams, depending on organizational needs. Provide QA oversight across clinical and commercial programs, ensuring phase-appropriate compliance and inspection readiness. Oversee, and/or support and execute core Quality Management System (QMS) processes, including batch record review, deviations, investigations, CAPAs, change control, OOS/OOT management, risk management, validation, and training compliance. Serve as the Quality assurance interface for contract manufacturing and testing organizations (CMOs), including review and approval of manufacturing documentation, analytical data, deviations, changes, and validation packages. Support and/or participate in real-time QA decision-making during critical manufacturing operations. Support and lead regulatory inspections, partner audits, and Qualified Person (QP) interactions. Review and approve technical and quality documentation, including validation reports, stability data, and APQR/QMR inputs. Utilize enterprise quality systems, including SAP and Veeva, to support compliant and efficient quality operations. Support continuous improvement initiatives to enhance compliance, efficiency, and product quality. Collaborate cross-functionally with Technical Operations, CMC, Regulatory, Clinical, Supply Chain, and IT teams. Communicate quality- or supply-impacting issues clearly to internal and external stakeholders. Support new quality initiatives and cross-functional projects Apply strong cGMP knowledge in daily activities Perform additional duties as assigned REQUIREMENTS: Bachelor’s degree in Chemistry, Biological Sciences, Engineering, or a related discipline At least 5 years of pharmaceutical industry experience, including experience in Quality Assurance within a cGMP environment. Demonstrated experience supporting Drug Substance manufacturing across both clinical; limited commercial experience is a plus but not required. Experience working with CMOs/CDMOs, including oversight of manufacturing, testing, and release activities knowledge of global cGMP regulations (FDA, EMA, ICH, etc.). SAP and Veeva systems experience Strong analytical, technical, and critical-thinking skills. Excellent written and verbal communication skills. Ability to manage multiple priorities and adapt to changing business needs. Please visit our website, http://www.ionis.com (http://www.ionis.com/) for more information about Ionis and to apply for this position; reference requisition # IONIS004115 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits (https://ionis.com/careers#:~:text=Highly%20competitive%20benefits) Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits (https://ionis.com/careers#:~:text=Highly%20competitive%20benefits) The pay scale for this position is $70,844 to $126,585 The pay scale for the Manager position is $70,844 to $102,371 The pay scale for the Senior Manager position is $87,530 to $126,585 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! EXECUTIVE DIRECTOR, GMP QUALITY SUMMARY: The Executive Director, GMP Quality is a senior QA leadership position and the senior GMP Quality leader supporting the Carlsbad campus. The position provides strategic direction and leadership for GMP Quality activities and initiatives across the drug development lifecycle through clinical and commercial supply, including internal operations and activities managed through CMOs and other service providers. The position is accountable for ensuring effective GMP Quality oversight and for developing and enhancing QA operations in accordance with applicable cGMP requirements. The scope of the position includes drug substance and drug product manufacturing support and related GMP Quality activities at the Carlsbad campus and Faraday facility, as well as activities conducted internally by Ionis and externally through CMOs and other service providers. The position is accountable for strategic oversight of Quality relationships with Ionis business partners and serves as a key interface for domestic and international regulatory GMP inspections, audits, and partner communications as they relate to Quality. The position leads audit and inspection readiness activities and serves as the lead QA representative during health authority inspections of the Faraday campus. The Executive Director, GMP Quality reports directly to the Vice President of GMP Quality. WORK LOCATION: onsite in Carlsbad, CA CORE RESPONSIBILITIES: Provide strategic leadership and direction for GMP Quality activities supporting the Carlsbad campus, Faraday facility, and Ionis development lifecycle products manufactured internally or outsourced to CMOs. Lead the establishment and enhancement of GMP Quality processes for clinical supply, drug substance and drug product manufacturing, testing, and release activities in accordance with applicable GMP regulations and guidelines (e.g. EU, FDA, HC, ICH, MHLW, TGA, etc.). Provide senior QA expertise and strategic guidance on quality issues, including manufacturing deviations, investigations, CAPAs, change controls, OOS/OOT results, and other GMP matters. Lead and influence relationships with CMOs, business partners, Technical Operations, Manufacturing, QC, Regulatory, and Ionis leadership to support risk management, issue resolution, continuous improvement, and a culture committed to quality excellence. Provide strategic Quality direction and oversight for Ionis' new compounds, new chemistries, and novel manufacturing processes, as applicable. Lead audit and inspection readiness for the Carlsbad campus, Faraday facility, and external service providers; lead the development of responses to health authority observations; and serve as the lead QA representative during health authority inspections of the Faraday campus. Lead the development and enhancement of Quality policies, programs, procedures, and training to support Ionis business objectives and promote consistent GMP Quality standards. REQUIREMENTS: Minimum of 20 years of QA, GMP Quality, or compliance experience, with 10+ years of senior leadership experience leading and developing a Quality organization in a pharmaceutical or biotechnology manufacturing setting. Demonstrated success providing strategic direction, developing Quality processes and procedures, and establishing a culture committed to Quality excellence. A degree in a relevant scientific, engineering, pharmacy, or related discipline is preferred. Significant experience with regulatory inspections, audits, investigations, CAPA, change control, risk management, and applicable USA/global GMP requirements. Experience with biologics and drug substance and/or drug product manufacturing is required experience with aseptic products, combination products, or other complex pharmaceutical operations is preferred. Proven record of strong senior-level people, program, communication, stakeholder-management, influencing, and strategic leadership skills, with the judgment to establish priorities, manage risk, and escalate quality issues appropriately. Demonstrated ability to lead cross-functional initiatives, coach and mentor colleagues, represent Quality with internal and external stakeholders, and drive compliant, sustainable improvements while maintaining alignment with established functional accountabilities. - this is a run on, we need to shorten Demonstrated ability to lead cross-functional initiatives; coach and mentor colleagues; represent Quality with internal and external stakeholders; and drive compliant, sustainable improvements aligned with established functional accountabilities. Please visit our website, http://www.ionis.com (http://www.ionis.com/) for more information about Ionis and to apply for this position; reference requisition #IONIS004102 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits (https://ionis.com/careers#:~:text=Highly%20competitive%20benefits) Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits (https://ionis.com/careers#:~:text=Highly%20competitive%20benefits) The pay scale for this position is $221,151 to $288,783 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
Description: The Library Director supports the Library Systems & Services (LS&S) mission, vision, and values through strong leadership and a commitment to exceptional customer service. This position is responsible for the overall management and operations of the Escondido Public Library, ensuring contract requirements are met and the library continues to serve as a valuable resource within the community. The Library Director leads and supports a team of library staff, builds strong relationships with local officials and community partners, and manages the overall customer relationship. This position reports to the Vice President, Operations. Position Details: Location: Escondido Public Library Full-time, 40 hours per week Exempt On-site position; this is not a remote position PRIMARY RESPONSIBILITES An individual must be able to perform each essential duty and responsibility satisfactorily. Leads with integrity, honesty, and professionalism while promoting the culture, values, and mission of LS&S. Oversees the day-to-day operations of the Escondido Library and ensures contract and operational requirements are met. Evaluates library operations and key performance indicators to identify concerns, opportunities, and areas for improvement. Leads, coaches, and develops library staff to achieve operational goals and provide excellent customer service and patron experiences. Manages day-to-day staffing needs while consulting with and keeping the Vice President, Operations informed. Evaluates employee performance, provides ongoing feedback, and supports employee development. Develops and implements action plans to meet operational and organizational goals. Stays current on library trends, issues, technology, and community needs that may impact library services and programming. Plans and executes local, regional, and company initiatives and follows up to ensure accountability and results. Utilizes available tools, resources, and best practices to support effective library operations. Reviews financial reports, library usage data, demographics, trends, and other information to identify and address operational needs. Oversees the selection, acquisition, and processing of library materials in accordance with collection development policies and budget requirements. Manages and maintains positive relationships with local officials, governing bodies, library boards, and other key stakeholders. Regularly seeks feedback from clients, stakeholders, and patrons to better understand and respond to community needs. Maintains a positive, healthy, and safe work environment in accordance with applicable laws, regulations, and company policies. Oversees the implementation and consistent application of human resources policies, procedures, and practices. Understands and administers the American Library Association’s Library Bill of Rights, Freedom to Read Statement, and Freedom to View Statement, while supporting client requirements related to materials available at the library. Follows all legal and policy requirements related to patron privacy and the custodianship of patron records. Performs other duties as assigned. Requirements: JOB REQUIREMENTS Candidates should possess the knowledge, skills, and abilities listed below and meet the required education, training, and/or work experience. MLS/MLIS or equivalent required. Four years of supervisory or leadership experience preferred. Five years of progressively responsible library management and/or administrative experience, or equivalent experience, preferred. Experience analyzing and applying financial reports and library-related data, including usage, demographics, and trends, preferred. Working knowledge of library programming, budgeting, and financial management. Experience working directly with patrons, responding to requests, and addressing patron questions, concerns, and feedback. Regular and reliable attendance is required. CORE COMPETENCIES The Library Director should demonstrate the following: Remains flexible and effective in a changing work environment. Demonstrates integrity and ensures decisions and actions align with organizational values and standards. Develops and maintains positive working relationships with staff, clients, community partners, and other stakeholders. Communicates clearly, professionally, and effectively through verbal and written communication. Identifies new ideas and opportunities to improve library operations, programs, and services. Understands and responds to the needs of internal and external clients while working within organizational guidelines. Builds a collaborative environment and works effectively with others to achieve shared goals. Positively influences, develops, and supports others to achieve organizational goals. Assesses situations, priorities, and risks and makes timely, sound decisions. Effectively manages priorities, deadlines, information, and multiple responsibilities. Establishes goals, develops action plans, monitors progress, and evaluates results. Identifies issues, gathers relevant information, evaluates solutions, and takes appropriate action. Considers organizational goals, community needs, trends, and changing conditions when making decisions. Physical Requirements and Working Conditions: Work is primarily performed in a public library and office environment with regular interaction with staff, patrons, and community members. Requires the ability to use a computer and other standard office equipment for extended periods. Requires vision, with or without correction, sufficient to read printed and electronic materials. Requires the ability to sit and/or stand for extended periods and maintain focus while working on a computer or reviewing detailed documents. Requires mobility to stand, walk, stoop, reach, and bend as needed to perform job duties. Requires sufficient hand and arm mobility and dexterity to grasp and handle books, materials, and office equipment. Requires the ability to occasionally lift, push, and/or pull items weighing up to 25 pounds, including books, files, and other library materials. May require working evenings and/or weekends based on operational needs. Benefits Health Care Plan (Medical, Dental & Vision) Tuition Assistance Retirement Plan (401k) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays) Short Term & Long-Term Disability Training & Development Wellness Resources EEO STATEMENT The company and its subsidiaries are an equal opportunity employer and celebrate the population of differences and does not discriminate in its hiring/hiring practices, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by law. Nothing in this job specification restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Critical features of this job are described under various headings above. They may be subject to change at any time due to reasonable accommodation or other reasons. The above statements are strictly intended to describe the general nature and level of the work being performed. They are not intended to be construed as a complete list of all responsibilities, duties, and skills required of employees in this position. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.