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Corporate Overview Argonaut Manufacturing Services Inc. is a leading contract development and manufacturing organization (CDMO) specializing in aseptic fill-finish services for pharmaceutical and biopharmaceutical products. Headquartered in Carlsbad, California, Argonaut supports clients from clinical development through commercial manufacturing, with a focus on product quality, yield optimization, and reliable delivery. Argonaut provides flexible drug product manufacturing solutions, including vial, syringe, and cartridge filling, as well as combination filling capabilities. The company also offers analytical services and short-term cGMP storage to support clients throughout the manufacturing process. With a commitment to quality standards and hands-on client support, Argonaut works closely with customers to help ensure consistent, compliant, and efficient manufacturing while meeting critical timelines and patient needs. Benefits and Pay Range Benefits for this position, subject to applicable eligibility requirements. Medical Insurance Dental Insurance Vision Insurance Company Paid Life Insurance 1X annual Salary Voluntary Life Insurance Long-Term Disability Insurance and Short-Term Disability Insurance Flexible Spending Account and Health Saving Account 401(K) Retirement Plan 10 Days of Paid Time Off 10 Paid Holidays Annually The pay range for this position is between $117K - $128K annually. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. Position and Scope The QC Project Manager leads and coordinates Quality Control projects and programs from initiation through completion, ensuring alignment with business objectives, customer expectations, regulatory requirements, timelines, and financial goals. The role serves as a key cross-functional liaison between QC, QA, Program Management, Finance, customers, and external partners, providing project leadership, risk and resource management, issue resolution, and performance oversight. This role is 100% On-Site, Monday – Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00am and 9:00am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance. Responsibilities and Duties Lead end-to-end QC project management for complex pharmaceutical and biopharmaceutical programs, including project scope, timelines, milestones, resources, risks, deliverables, testing priorities, and customer commitments. Serve as the primary QC project lead, coordinating activities across QC, QA, Project Management, Finance, customers, and external laboratory partners to ensure timely, compliant, and efficient execution. Translate customer requirements into executable testing strategies, project plans, resource requirements, regulatory deliverables, and compliance objectives. Manage stability programs from study initiation through testing, data review, reporting, and completion, ensuring adherence to protocols, schedules, SOPs, quality requirements, and customer commitments. Ensure QC testing readiness across personnel, equipment, analytical methods, documentation, and laboratory systems, while proactively identifying and resolving operational risks and resource constraints. Participate in root cause investigations, CAPAs, change controls, remediation efforts, and continuous improvement initiatives to strengthen quality, compliance, and operational efficiency. Utilize project metrics to monitor performance, identify trends and resource gaps, and provide data-driven insights to support project and business decisions. Partner with Finance to track project activities and billable work, assign costs to appropriate customer and GL accounts, support accurate invoicing, and reconcile financial activity with approved project scope. Manage project governance and executive communications, including status reporting, risks, milestones, resource and financial updates, escalations, and key decisions. Participate in effective customer and stakeholder relationships through clear communication, alignment on requirements and deliverables, and timely resolution of project issues. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Requirements and Qualifications Bachelor's degree in chemistry, biochemistry, biology, pharmaceutical sciences, or a related scientific discipline. 5+ years of experience in pharmaceutical, biopharmaceutical, or other GMP-regulated environments, including Quality Control experience. 3+ years of experience in QC project management, laboratory operations, stability management, or related project leadership. Demonstrated experience managing multiple concurrent projects and cross-functional teams in a regulated environment. Strong working knowledge of GMP, QC laboratory operations, stability programs, analytical testing, data integrity, and quality systems. Experience with project planning, scheduling, risk management, resource coordination, and customer deliverables. Experience with deviations, investigations, CAPAs, change controls, and audit/inspection readiness. Proficiency with Microsoft Office; experience with Power BI or similar reporting tools preferred. Strong analytical, organizational, communication, and problem-solving skills, with the ability to work independently and effectively engage senior leadership and customers. Argonaut Manufacturing Services, Inc. is an equal opportunity employer committed to providing equal employment opportunities to all employees and applicants. We make employment decisions without regard to race, color, religion, sex, gender identity or expression, sexual orientation, pregnancy, national origin, ancestry, age, disability, genetic information, veteran or military status, marital status, or any other characteristic protected by applicable federal, state, or local law. Argonaut Manufacturing Services, Inc. complies with all applicable employment eligibility verification requirements. Candidates must be legally authorized to work in the United States. Employment eligibility will be verified in accordance with applicable federal law.
*Job Summary* We are seeking a proactive and detail-oriented Set-Up Technician to join our manufacturing team. In this role, you will be responsible for preparing and configuring machinery and equipment to ensure smooth production runs. Your expertise will help optimize machine performance, maintain high-quality standards, and uphold safety protocols across various manufacturing processes. This position offers an exciting opportunity to work with advanced industrial equipment and contribute to efficient plastics production operations. Responsibilities: Set-up jobs to meet production schedules. Assure job set-up has the ability to meet quality requirements by producing acceptable first article run. Run special tasks as assigned by the Foreman. Make unassisted machine adjustments or offsets. Qualifications: ideal candidate 3+ years experience in a job shop environment with set-up experience. Formal education or trade school desirable, although can substitute job shop experience for formal education. Fanuc, Celos, G-code, Mastercam, (editors- CIMCO or VS code) Physical requirements: Must be able to lift 25 lbs. Duties: * Create fixtures * Speed-up jobs (Make adjustments to programs) * Assist with machine break down & repair (troubleshoot) * Communicate with production manager & scheduling for planning * Operate machines * Assist with QC duties as needed- Create check sheets * Assist with new set-up personnel (shadow, suggest & Improve) * Monitor when new tooling is used to ensure proper speeds & feeds are being used. * When something is broken, follow through with repair to completion, if you can’t fix it find an alternative (purchase new item or get outside repair) This role is ideal for candidates passionate about manufacturing technology who thrive in a fast-paced environment dedicated to quality excellence! Pay: $30.00 - $38.00 per hour Expected hours: 40.0 per week Work Location: In person
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: Welcome to our dynamic team, where we pioneer the development of processes and equipment for all iterations of Dexcom wearables and applicators. From cutting-edge research concepts to the efficient production machinery responsible for crafting millions of sensors annually, our team plays a pivotal role in shaping the future of Dexcom technology. Join us in this exceptional and thrilling work environment within a stellar company, where your technical prowess and creative contributions directly influence the lives of our customers daily, both now and in the days to come. Where you come in: You own the development and characterization of the process and equipment from concept to implementation on the line. This will start out on a pilot scale and ramp to full production depending on project phase. You develop and maintain project timelines and provide updates and feedback to project leadership. You will apply knowledge of biosensing and signal processing to develop sensor fabrication processes and lead DOEs to be able to down select a capable process. You will solve the problem with a highly diverse and cross-collaborating team. You will work on processes that support biosensing fabrication including technologies related to coating & laser cutting. You will partner with vendors to develop equipment and integrate into Dexcom processes to provide feasibility processes & high capability scale processes. You lead and guide a team of engineers who do similar work. You apply strategic plans aligned with the business targets to ensure the team delivers a cohesive manufacturing process and line. You implement inspections, measurement system analysis and perform capability analysis. You develop test plans, protocols and reports to document the concept and feasibility activities. You provide technical oversight and coordinate Research and Development builds within a pilot production facility for multiple projects and project teams. You also train technicians and operators to use the processes and equipment. You identify process risks and track mitigations through standard methods. You assist in scaling up equipment and processes from prototype to pilot to full scale manufacturing. Provide design and assembly requirements working within scope as determined by business and schedule needs. You create and release equipment specifications and drawings, establish calibration and preventative maintenance requirements. What makes you successful: You demonstrate excellent interpersonal and communication skills with demonstrated ability to coordinate and prioritize activities to meet objectives on time and with a high level of quality You can evaluate and apply design tradeoffs and constraints for design optimization. You have a demonstrated history of running self-directed projects, managing timelines, completing technology transfer, and executing projects in an R&D environment. You are able to think at a high strategic level down to a task-based level and switch between the two easily. You are a good mentor and leader. You are adept at data analysis methods and analysis software, with the ability to construct appropriately powered and creatively designed experiments to solve complex problems. You demonstrate effective technical writing skills, including ability to write protocols, design of experiments (DOEs) and other technical reports and documents. You have an ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things. You have extensive knowledge of high reliability, high volume manufacturing processes and designs. You have the ability to work hands-on in a fast-paced environment. What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community . A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 0-5% Education and Experience: Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [email protected]. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [email protected]. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people. Salary: $128,600.00 - $214,400.00 #DexcomUS
The Safety Process Engineer will focus on the development, implementation, and support of a Process Safety Management (PSM) system for operations at Bachem sites. The incumbent collaborates in the development, implementation, and support of the HSE management system and will champion the PSM effort. This position leads the risk effort in PSM and also assists with collecting key performance indicators, maintaining HSE compliance documentation, and making recommendations for continual improvement of PSM & HSE systems. What you will do Manages HAZOPs performs safety assessments and HAZIDs. Provide training and mentorship to members of the team. Independently verify completion of high-risk PHA recommendations, Audit findings, and other high-risk mitigative actions across all facilities. Evaluate risks associated with identified hazards in alignment with company and regulatory processes. Be facility point of contact for OSHA, EPA, and RAGAGEP regulations/standards as they pertain to the covered process. Knowledgeable of Emergency Planning requirements and ICS structure. Ensures effective communications among other engineering disciplines. Develop and maintain process safety standards, procedures, and forms that comply with internal and external regulations. Facilitate the effective implementation of process safety across the organization. Interface with clients, understand their process safety challenges, and offer tailored solutions. Assist in the development and implementation of the process safety management (PSM) and risk management program (RMP) Corporate requirements. Qualifications Bachelor's Degree Chemical or Mechanical Engineering or related field required or Bachelor's Degree in science or related field with 5+ years of experience in a chemical background with specific process safety experience required or Associate's Degree in science or related field with 10+ years of experience in a chemical background with specific process safety experience 7-9 years Of experience as a Process Safety Lead or Process Engineer in chemical/refinery industry or pharmaceutical industry required Familiar with common risk assessment and process hazards analysis methodologies e.g. FMEA, HAZOP, LOPA, Fault Tree, Cause & Effect, etc. Understands global process safety related regulations Intimated knowledge of PSM standards Develop PSM policies, standards and processes for Bachem regional sites Provide technical support for the implementation of PSM compliance and improvement programs and projects across Bachem sites Maintain up to date information about and interpret local, state and federal PSM regulations Develop and implement PSM risk assessment and risk management plans and emergency plans for new and existing processes Conduct critical PSM accident investigations and work with site teams to drive corrective actions to timely completion Review critical PSM audit, inspection and accident reports and recommend and/or implement corrective actions to eliminate recurrence Provide input regarding PSM priorities, budget and resources needed Monitor the application of the PSM key performance indicators, ensure compliance and interpret and report results, ensure actions are taken to mitigate or eliminate program gaps Base Annual Salary Range: $113,691.20-$156,325.40 Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status. At Bachem, you’ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation. Please note: unsolicited resumes from recruitment agencies will not be considered. Nearest Major Market: San Diego
Description: Summary The Quality Engineer I provides quality leadership and technical support to their Value Stream Team and quality technicians within Providien Thermoforming’s manufacturing operations. Working under the guidance of the Quality Manager, this role plans, initiates, coordinates, and evaluates activities related to the application, development, and maintenance of quality tasks, processes, and systems for thermoformed products. The primary responsibility of this role is to ensure that thermoformed components and assemblies meet required quality standards, customer expectations, and applicable regulatory requirements across our medical device, aerospace, and industrial markets. Essential Job Functions Provide daily quality support to manufacturing, Engineering, including inspection, assembly, packaging and shipping operations. Investigate nonconforming products, scrap, rework, and customer complaints; identify root cause and implement effective corrective actions. Lead or Support CAPAs using tools such as 5 whys, fishbone diagrams, and process data analysis. Develop and maintain inspection plans, work instructions, acceptance criteria and manufacturing quality records. Review production documentation for completeness, accuracy and compliance with GDP. Partner with manufacturing and engineering teams on process changes, validation activities, risk assessment and FAI. Use trend data, defects rates, and quality metrics to identify recurring issues and measure improvement. Support supplier quality activities, including evaluation of supplier non-conformances and corrective actions. Participate in internal, customers and ISO 13485 audits; help prepare responses and close finding on time. Train and coach employees on quality requirements and practical application of procedures on the manufacturing floor. Develop and implement standards and methods for inspecting, testing, and evaluating thermoformed products and components. Develop and deliver quality training materials to increase awareness across the Value Stream Team. Review of customer specifications Participate in the design and process of FMEAs, Design of Experiments, PPAPs, Process/Product Capability Studies, and Product Liability Meetings. Continuously improve quality systems and processes. Other duties as required in support of the department and the company. Supervisor Responsibilities This role does not include supervisory responsibilities over other employees. The Quality Engineer provides functional quality leadership and technical guidance to quality technicians within their assigned Value Stream Team. Requirements: Qualifications To perform this role successfully, an individual must be able to satisfy each essential function listed above. The requirements below represent the knowledge, skills, and abilities needed. Reasonable accommodations may be made for individuals with disabilities. Education and Experience Bachelor’s degree in engineering or sciences, or 5+ years of experience working in a technical engineering role. Minimum of 3 years of experience in manufacturing preferred. Experience in Root Cause Analysis investigation (5 Whys, Fishbone, 8D, etc.) is preferred. Knowledge of ISO 13485:2016 and other relevant quality standards preferred Proven experience in a manufacturing quality control role. Background in medical device, aerospace, or plastics/thermoforming manufacturing industries is preferred. Certificates, Licenses, and Registrations ASQ Certified Quality Engineer (CQE) or Certified Quality Process Analyst (CQPA) preferred. Six Sigma Green Belt preferred. Language Requirements Excellent verbal and written communication skills in English are required. Mathematical Skills Basic arithmetic: add, subtract, multiply, and divide whole numbers, fractions, decimals, and percentages. Statistics: interpret and analyze numerical data using statistical methods. Basic algebra: manipulate symbols and equations to find unknown values, express relationships, and model situations. Basic geometry: understand and work with shapes, angles, lines, and planes. Basic trigonometry: understanding essential trigonometric functions and how they relate to engineering drawings and specifications. Technical Skills Proficient in MS Office Suite and SharePoint. Able to learn new business systems and associated software efficiently. Knowledge of ERP systems preferred. Excellent knowledge of blueprint reading, Geometric Dimensioning & Tolerancing (GD&T), and ASME Y14.5M. Excellent analytical, problem-solving, and attention-to-detail skills. Strong team player with the ability to collaborate across departments. Strong communication skills to effectively convey standards and procedures. Reliable and flexible to work additional hours on short notice to complete orders or special projects to meet customer or internal demands. Able to work independently with minimal supervision. Physical Demands The employee must be able to sit, stand, and walk throughout the workday. They frequently use their hands to handle objects and must communicate verbally. The role may also require reaching, crouching, stooping, and occasionally lifting objects up to 50 pounds. Specific vision abilities required include close, distance, color, and peripheral vision, depth perception, and the ability to adjust focus. Reasonable accommodation will be provided in accordance with ADA regulations. Work Environment Work is performed on the production floor of a manufacturing facility. Conditions may include exposure to machinery, noise, temperature variation, and other physical workplace factors. A culture of safety, teamwork, and continuous improvement is expected. Environmental Policy Providien Thermoforming is committed to minimizing the environmental impact of its operations, activities, and products. We comply with all applicable environmental regulations, work to prevent pollution, and continuously improve our environmental performance. Our Environmental Management System provides a framework for setting and reviewing environmental objectives and targets. Personal Protective Equipment Requirements Safety toe footwear meeting ASTM F-2412-2005, ANSI Z41-1999, or ANSI Z41-1991 standards in designated areas. ANSI Z87.1 safety-rated clear glasses in designated areas. Hearing protection in designated areas. Compliance with applicable Job Safety Analysis (JSA) requirements. Travel Approximately 15% travel is expected for this role. Providien Thermoforming does not accept unsolicited resumes or candidate submissions from external recruiters or staffing agencies for this position. Any resumes submitted without a signed agreement in place will be considered the property of Providien Thermoforming, and no placement fee will be paid.
About Artiva: We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell-killing properties of NK cells, when combined with mAbs for targeting, create an opportunity to generate potentially transformative therapies. For more information, visit www.artivabio.com Join Artiva Biotherapeutics in San Diego and work directly on the manufacturing floor to produce our innovative, off-the-shelf cell therapies in a state-of-the-art cGMP facility. Apply your expertise across cell culture, aseptic processing, harvest and fill-finish, playing a direct role in advancing therapies for patients with autoimmune diseases. This is a contract-only position. Summary The successful candidate will play a key role in the manufacturing of cell therapies internally at Artiva. He/ she will execute hands-on manufacturing processes to deliver new revolutionary therapeutics. The ideal candidate will demonstrate in-depth knowledge of cGMP compliance, strong hands-on laboratory skills and work in a high-performing team of manufacturing associates. Key Responsibilities Execute GMO manufacturing operations including cell expansion, harvest, and fill-finish. Perform Aseptic Process Validation and participate in annual aseptic qualification. Follow cGMP standards and procedures to maintain compliance. Support development of batch records, workflows, and SOPs in accordance with regulatory and GMP requirements. Apply cell culture expertise to media/buffer preparation, cell passaging, bioreactor production, and harvesting. Lead after-action reviews to improve operational efficiency and KPIs, identify process gaps/risks, and implement sustainable improvements. Support equipment and process change controls through implementation. Work in Grade B and Grade C cleanroom environments. Perform hands-on manufacturing operations directly on the floor. Qualifications Bachelor’s degree in a relevant science or engineering discipline, or equivalent work experience. Minimum 1 year of cGMP biologics or cell culture manufacturing experience; biotech or cell therapy experience preferred. Preferred experience with: Aseptic gowning and ISO 7 cleanroom manufacturing Cell counting platforms Cell culture and expansion using bag systems and single-use large-scale bioreactors; Sartorius experience a plus Lentiviral transduction Automated and manual cell harvesting/washing; LOVO experience a plus Cell selection/depletion using Miltenyi CliniMACS Prodigy Fill-finish and cryopreservation in bags and vials; M1 filler and AT-vial experience a plus Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Innovative, adaptable, and able to apply best practices in a small, growing environment. Self-motivated with strong ownership, organizational skills, and the ability to prioritize and deliver results on time. Working Conditions and Physical Requirements Work with cells and cell lines of human origin. Ability to stand and work gowned for prolonged periods. NO AGENCIES PLEASE In addition to a great culture, we offer: A beautiful facility An entrepreneurial, highly collaborative, and innovative environment If all this speaks to you, come join us on our journey! Base Salary: $36-$50 per hour. Exact compensation may vary based on level, skills, and experience.
Location - Vista, CA - Hybrid Salary - 109K - 129K POSITION SUMMARY The Quality Management Systems (QMS) Manager is responsible for overseeing, standardizing, and advancing Nordic Naturals' quality management systems across headquarters and manufacturing facilities (Watsonville and Vista). Reporting directly to the Director of Quality, this role spearheads the development and implementation of an integrated electronic Quality Management System (eQMS). The QMS Manager oversees core compliance functions—including Document Control, Change Control, Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), Deviations, and Internal/External Quality Audits—ensuring rigorous cGMP compliance under 21 CFR Part 111 and 21 CFR Part 11 while driving a culture of continuous quality improvement. Reasonable Accommodations Statement To accomplish this job successfully, this individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions. ESSENTIAL FUNCTIONS eQMS Implementation & Governance: Lead the evaluation, integration, and administrative oversight of a unified electronic Quality Management System (eQMS) bridging multi-site operations (HQ, Vista, and warehouse locations). Document & Change Control Management: Oversee the Document Control team and manage Change Control (CCO/CCR) processes to ensure all Standard Operating Procedures (SOPs), Master Formulas, and Packaging Specifications strictly adhere to cGMP standards. CAPA & Non-Conformance Oversight: Direct cross-functional Non-Conformance Report (NCR) and Corrective and Preventive Action (CAPA) investigations and execution through an eQMS or other existing forums, ensuring timely execution of investigation and implementation steps. Audit Program Leadership: Manage the internal cGMP audit schedule across production, compounding, packaging, and laboratory areas. May need to be present for as a quality contact during FDA, NSF, and third-party regulatory audits. Cross-Functional Collaboration: Partner closely with Manufacturing, Operations, Product Development, and Technical Engineering teams to streamline quality workflows, eliminate production bottlenecks, and support new product launches and plant trials. Metrics & Quality Reporting: Establish, track, and report key quality performance indicators (KPIs) and monthly metrics (investigation cycle times, CAPA resolution rates, SOP gap closures) to the Director of Quality and leadership. Team Leadership & Development: Supervise, mentor, and evaluate direct reports within Quality Systems and Document Control, establishing clear accountabilities and professional development pathways. POSITION QUALIFICATIONS Competency Statements Leadership: Ability to influence cross-functional teams, drive accountability, and foster a collaborative, compliance-minded quality culture. Problem Solving & RCA: Advanced analytical capabilities in root cause investigation (RCA) and risk mitigation (FMEA, HACCP). Detail Oriented: Exceptional precision in evaluating complex documentation, batch records, investigations, and regulatory standards. Communication: Outstanding written and verbal communication skills for presenting quality findings and leading regulatory audit defense. Strategic Thinking: Ability to align QMS objectives with long-term corporate growth and operational scale. SKILLS & ABILITIES Education: Bachelor's degree in chemistry, Biology, Bioengineering, Quality Systems, or related scientific discipline required. Master's degree, PCQI or ASQ certification preferred. Experience: 5+ years of direct experience in Quality Assurance or Quality Engineering within a cGMP dietary supplement, food, or pharmaceutical manufacturing environment, with 3+ years in a supervisory/management capacity. Computer Skills: High proficiency with Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) software (e.g., SAP). Working knowledge with PLM/eQMS software platforms, Filemaker, Smartsheet. Advanced knowledge of Microsoft Office Suite (particularly Excel for data tracking, Word for SOP drafting, and PowerPoint for training delivery).
Corporate Overview Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence Benefits and Pay Range At Argonaut Manufacturing Services we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy: Medical, Dental, and Vision Insurance Company-Paid Life Insurance (1x Annual Salary) Voluntary Life Insurance Options Short-Term and Long-Term Disability Insurance Flexible Spending Account (FSA)Health Savings Account (HSA) 401(k) Retirement Plan with Company Matching 10 Days of Paid Time Off (PTO) 10 Paid Holidays Annually The pay range for this position is $74,000 - $80,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications. Position Overview The purpose of this position is to perform tasks pertaining to assurance compliance with quality requirements, including leading quality investigations, managing client complaints, and reviewing production batch records and associated documentation required to release a production lot. This role also supports the investigation and resolution of customer complaints, deviations, and internal non-conformance events, helping drive CAPA and continuous improvement efforts. This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Hours are 9:00 am - 5:30 pm with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance. Responsibilities and Duties Review production records and associated documentation for lot disposition Prepare Certificate of Compliance (COC) and review Certificate of Analysis (COA), as required Perform line clearance functions for cGMP processes Support manufacturing operations and staff to address product quality and compliance issues, as they arise Initiate, lead and/or assist investigations into quality issues such as complaints, Corrective and Preventive Actions (CAPAs), and non-conformances Perform visual inspection of finished product Manage client complaints Oversee facility/cleanroom cleaners to ensure they are fully trained and have documented training for current Argonaut/Aluris procedures, have current unexpired cleaning forms available, and maintain annual gowning requalifications as applicable Perform facility walkthroughs to ensure cleanrooms, laboratories, warehouse, etc. remain in compliance Requirements and Qualifications Bachelor's degree in Life Sciences discipline or equivalent is preferred Minimum four (4) years of relevant experience Must be able to effectively communicate within the department and cross-functionally with other divisions High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction Experience with MasterControl and NetSuite a plus Superior attention to detail, organizational skills, and the ability to multi-task in a time- line driven environment Experience working in the life science and/or pharmaceutical manufacturing industry Proven problem-solving skills Excellent oral and written communication skills, and listening skills Working knowledge of cGMP regulations, 21 CFR 820, ISO 13485, and good documentation practices Ability to make decisions regarding quality of product and material Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.
Overview We are seeking a dedicated and skilled Machine Operator to join our dynamic team in Carlsbad, CA. In this role, you will play a crucial part in our production process, ensuring that our machinery operates smoothly and efficiently. If you have a passion for precision and a knack for troubleshooting, we want to hear from you! Responsibilities Operate and monitor machinery to ensure optimal performance and safety. Perform routine maintenance and troubleshooting on equipment. Read and interpret blueprints and technical drawings. Maintain accurate production records and reports. Collaborate with team members to meet production goals and deadlines. Adhere to all safety protocols and regulations. Assist in training new operators as needed. Identify and report any issues or malfunctions to management. Qualifications High school diploma or equivalent; technical certification is a plus. Proven experience as a machine operator or similar role. Strong mechanical aptitude and problem-solving skills. Ability to read and interpret technical documents. Familiarity with safety standards and practices in a manufacturing environment. Excellent attention to detail and a commitment to quality. Ability to work independently and as part of a team. Flexibility to work various shifts as needed.
Job Description JOB OVERVIEW We are seeking an organized, detail-oriented Quality Assurance Production Technician to join our QA team. In this role, you will execute daily inspection and test activities for our hardware products, ensuring every device leaving the production line meets our standards for quality and reliability. This position reports to the QA Supervisor. Key Responsibilities Coordinate activities to meet daily throughput targets Partner with the Production Manager to ensure adequate resources are available for hit testing Participate in morning stand-ups and production meetings; report daily throughput along with any problems, impediments, or blockers Test devices coming off the production line, including: Visual inspection and classification of cosmetic defects Functional testing of electronic systems Execution of test scripts, ensuring related documentation and workflow are completed correctly Perform software testing as needed Execute research tests and experiments; organize, analyze, and present the results Support all company sales and promotional efforts as required. Qualifications Required Prior experience in a quality assurance, manufacturing, or production environment Strong written and verbal communication skills Proficiency with Microsoft Excel and general PC applications Comfort following and improving detailed written test procedures Preferred Experience with consumer electronics or precision hardware manufacturing Experience with inspection or production data collection tools Physical Requirements Standing for extended periods Lifting up to 30lbs Close visual inspection work Pay Range: Hourly Rate: $20.00 - $23.50 The actual annual salary offered to a candidate will be based on variables including experience, geographic location, education, and skills/achievements, and will be mutually agreed upon at the time of offer. We offer a highly competitive salary, comprehensive benefits including: medical and dental, vision, disability and life insurance, 401K, PTO, paid holidays, gear discounts and the ability to add value to an exciting mission! Our Postings are not intended for distribution to or use in any jurisdiction, country or territory where such distribution or use would violate local law or would subject us to any regulations in another jurisdiction, country or territory. We reserve the right to limit our Postings in any jurisdiction, country or territory. Equal Opportunity Employer Protected Veteran/Disabled
Job Description JOB OVERVIEW FSS QA Hit Tester- Assists for all production, RMA and Marketing devices to ensure that quality products both functionally & cosmetically are completed per schedule in the most efficient manner possible. Completes checklist process for each device and updates the process per quality feedback from our customers. Communicates & coordinates with QA Supervisor quality information with Production & Engineering personnel for failure & root cause analysis for product improvements. This position reports to the QA Hit Tester, Supervisor. As the QA Hit Tester, you will have an opportunity to: Coordinate Quality Assurance Tecnicians activities to make sure it meets daily throughput needs. Coordinate with Production Manager to ensure available resources for hit testing. Participate in Morning stand-up / production meetings, report daily throughput. Report any problems, impediments, or blockers. Test devices coming out of production line, including: Visual inspection and classified cosmetic defects; Functional test of electronic functions; Hit testing using several golf clubs, applying typical golf swings Follow test scripts and esure related documentation and workflow is completed correctly. Perform software testing as needed. Execute research tests and experiments; organize and present results. Support all company information technologies efforts as required Support all company sales and promotional efforts as required. Continues to build knowledge of the organization, processes, and customers You have the following qualifications that are necessary for someone to fill this position: Excellent communication skills Organized Experienced golfer PC Skills Pay Range: Hourly Rate: $25.00 - $28.50 The actual annual salary offered to a candidate will be based on variables including experience, geographic location, education, and skills/achievements, and will be mutually agreed upon at the time of offer. We offer a highly competitive salary, comprehensive benefits including: medical and dental, vision, disability and life insurance, 401K, PTO, paid holidays, gear discounts and the ability to add value to an exciting mission! Our Postings are not intended for distribution to or use in any jurisdiction, country or territory where such distribution or use would violate local law or would subject us to any regulations in another jurisdiction, country or territory. We reserve the right to limit our Postings in any jurisdiction, country or territory. Equal Opportunity Employer Protected Veteran/Disabled
About Nucleus Biologics: At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations. Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability. JOB SUMMARY: Nucleus Biologics™, The Cell Performance Company™, is the leading provider of custom cell-growth media, tools, and technologies for cell and gene therapy. Our mission is to speed the time from scientific discovery to cure by delivering innovative, transparent and cGMP products and services with the goal of disrupting the market and eliminating antiquated practices and products. We have multiple state-of-the-art facilities where we manufacture our products. The QC Analyst I is responsible for executing routine quality control activities, including in-house environmental monitoring (static and dynamic) and water testing, in-process quality monitoring during manufacturing events and incoming quality inspections. This role ensures compliance with applicable regulations and internal quality standards while supporting laboratory operations, data entry and trending, and inventory management. The QC Analyst I will also contribute to maintaining an efficient and compliant QC laboratory through the execution of daily and weekly tasks. RESPONSIBILITIES: Environmental Monitoring & Water Testing Perform routine environmental monitoring of classified and non-classified areas (air, surface, and personnel). Perform personnel and environment monitoring during manufacturing runs. Conduct high-purity water testing in accordance with USP <645> and other applicable standards. Quality Control Testing Conduct testing of raw materials, in-process samples, and finished products to verify compliance with product specifications and regulatory requirements. Testing may include: FTIR, Raman (Identity Testing); training provided USP compendial released testing (i.e. pH, Osmolality, Density, and Appearance) Support investigations of deviations, out-of-specification (OOS) results, and non-conformances, including documenting findings in accordance with established procedures. Support internal quality metrics reporting and participate in process improvement activities. Complete, archive and maintain raw material specification packets Laboratory Operations & Compliance May operate and/or assist with maintaining laboratory equipment such as autoclaves, incubators, microscopes, and endotoxin readers. Maintain accurate, complete, and compliant documentation of all QC activities, testing, analyses, and laboratory activities. May assist with preparing and reviewing SOPs, test methods, protocols, and reports. Support internal and external audits and follow laboratory practices aligned with cGMP and ISO 9001/13485 requirements. Assist with maintaining optimal inventory levels of reagents, media, and consumables. Ensure cleanliness, organization, and operational readiness of the QC laboratory. Support qualification and preventive maintenance activities for lab equipment. REQUIREMENTS: Bachelor’s degree in Chemistry, Microbiology, Biology, or a related field is preferred. A combination of education and/or relevant job experience may be considered. 1-3 years of experience in a QC laboratory within the pharmaceutical, biotechnology, or related regulated industry. Relevant cGMP laboratory internships may be considered. Cleanroom and gowning experience in ISO Class 7/8 areas required Experience with environmental/personnel monitoring, water testing, or microbiological/chemical testing methodologies preferred; training provided. Familiarity with USP and cGMP requirements; exposure to ISO 9001/13485 a plus. Strong organizational skills with attention to detail and the ability to manage multiple tasks. Proficiency in Microsoft Excel for data entry and basic trending; experience with LIMS or similar QC systems a plus. Excellent communication and documentation skills, with the ability to work cross-functionally in a fast-paced environment. ADDITIONAL SKILLS: · Ability to prioritize daily and weekly tasks and meet assigned deadlines · Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships · Strong attention to detail and process mindset · Ability to follow established procedures and escalate issues appropriately · Excellent verbal and written communication skills. · Familiarity with statistical process control methods a plus. PHYSICAL REQUIREMENTS: · Ability to hear and speak to employees and external associates on the phone and in person. · Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision) · Ability to wear full cleanroom gowning in accordance with ISO 7 and 8 requirements · Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions TRAVEL REQUIREMENTS: · None NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time. The pay range for this role is: 70,000 - 80,000 USD per year(10908)