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Position Summary The Quality Assurance Technician ensures food safety, quality, and compliance across all production activities. This role is critical in supporting manufacturing by identifying risks, conducting inspections, and verifying that all regulatory and Suja standards are met. This is an on-site position within a production environment and reports to the QA Supervisor. Schedule 1:00pm - 9:30pm, Tuesday- Saturday with flexibility to work overtime on Monday's Essential Duties and Responsibilities Monitor production conditions, specifications, process controls and tracking controls Monitor wash line concentrations and test ppm concentrations for sanitation bucket and floor solutions Monitor a system that will verify checks on existing production control forms and be audited on the same forms that meet all program requirements. Collect Lab retain samples Verify all CCPs on-line and take corrective actions whenever necessary to assist in determining the root cause and development of a preventative action plan Responsible for checking the pH levels, temperature and brix of each batch of juice produced and is with in product specifications Verify and document Facility Operation Inspections & Good Manufacturing Practices Enforce Good Manufacturing Practices (GMPs) throughout the manufacturing areas Perform Standard Sanitation Operational Procedures (SSOPs) verification and ATP swabs Tracks non-conforming product (Holds) Perform pre-operational inspection procedures of all production/bottling equipment and facility Verify equipment calibrations. Verify volumes, lot codes, torques & bottle weights are within product specification. Complete and enter into database all pallet tags and CCP forms for production and bottling. Record cycles and verify that all HPP settings and information is correct Perform metal mesh, magnet and sock mesh inspections Verify production lot codes, labels, mold number and packaging are within product specification Shipping and receiving verifications. Verification of all raw materials being delivered and labelled with accurate information at Receipt (product name, lots, expirations, quantity received) COA Reviewing, comparing to the specification, approving and filing the COA. Escalating or placing on hold any items that are out of compliance. Review and Verify receiving documents and logs. Monitors production conditions, specifications, process controls and tracking controls as they specifically relate to raw materials used in production. Document and maintain records for all raw materials used in the production process including disposals, usage, and pre-batching of ingredients. Materials will be logged on the appropriate batch ticket for raw material commodity of interest. Commodities include raw produce, frozen juice, frozen puree, dry ingredients and aseptic products. Inspect raw materials for deficiencies relating to appearance, texture, and/or odor before production use. Inspect incoming trailers to ensure compliance with receiving standards. Report any food safety problems to the SQF Practitioner or Department Supervisor in a timely manner so that corrective actions may be performed. Ability to understand and follow verbal and written instructions related to safety, equipment operation, and daily work assignments. Adhere to SOP, SSOP, GMP, and HACCP guidelines when in the plant. Ability to understand and follow verbal and written instructions related to safety, equipment operation, and daily work assignments. Regular and reliable attendance. Job Qualifications 1–2 years of experience in Quality Control and/or the food industry preferred Familiarity with food safety regulations is a plus Other Skills & Abilities Excellent communication skills Strong computer proficiency Sharp critical thinking and problem-solving abilities Flexible and able to adapt to change Capable of working independently with moderate supervision Comfortable in a fast-paced production setting Language Skills: Ability to communicate, read, listen, and understand English. Bilingual is a plus. Working Environment Regular exposure to wet, cold manufacturing environments (temperatures as low as 35°F) Occasional exposure to dry warehouse spaces or freezer conditions (down to -10°F) Frequent exposure to high noise levels (above 85 dBA) Requires use of PPE including safety glasses, ear protection, gloves, and steel-toed footwear Physical Requirements Ability to stand and walk for the full duration of the shift Must be able to frequently lift/move hoses, equipment, and chemical containers weighing up to 50 lbs Ability to push/pull up to 100 lbs with continuous motion Must be able to bend, kneel, squat, climb stairs/ladders, and reach overhead regularly Must have sufficient hand strength and manual dexterity to operate sanitation tools and machinery Must be able to pass a pre-employment physical Compensation and Benefits Come thrive at Suja Life! We offer a competitive benefits package, including: Hourly Pay: $20.00 Medical, dental, vision, life insurance, and more Paid Parental Leave – 12 Weeks at 100% Pay 401(k) match to help you plan for the future Paid time off: vacation, sick days & holidays Juice benefits: yes, we keep you fueled and refreshed! #ZR #INDHP Suja Life is proud to be an equal-opportunity employer seeking to create a welcoming and diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, ancestry, physical or mental disability, medical condition, marital status, genetics, age, or veteran status or any other applicable legally protected status or characteristic. The Company complies with all federal/local/state regulations regarding pay.
*T-Shirt Catcher Job Description* *Job Overview* We are seeking a dedicated and detail-oriented T-Shirt Folder to join our production team. In this role, you will be responsible for catching and handling freshly printed t-shirts as they come off the production line. Your attention to detail and ability to work efficiently in a fast-paced environment will contribute to the overall success of our manufacturing process. *Responsibilities* * Catch and properly handle t-shirts from the printing press, ensuring they are free from defects. * Organize, count, and stack finished products for quality control checks. * Assist with materials handling throughout the production area. * Collaborate with team members to maintain a smooth workflow on the assembly line. * Follow safety protocols and maintain a clean work environment. * Ability to stand for extended periods and perform repetitive tasks with precision * Strong organizational skills and a proactive attitude towards maintaining high standards of cleanliness *Skills*: * Basic math skills, able to count and memorize numbers. * Strong attention to detail and a good eye for colors. * Works well in a team setting. * Spanish speaking Join our team and play a vital role in delivering high-quality t-shirts while developing your skills in a dynamic manufacturing environment! Pay: $17.50 - $19.00 per hour Benefits: * 401(k) * 401(k) matching Work Location: In person
*About Us:* LIGHT Helmets is a leader in football safety equipment, dedicated to providing top-quality helmets for all levels of play. We are currently seeking a detail-oriented and skilled individual to join our team as a Helmet Assembly Technician & Reconditioning Specialist. *Key Responsibilities:* * Assemble helmets according to company specifications and safety standards * Inspect, repair, clean, and recondition used helmets to ensure they meet safety and quality guidelines * Perform quality control checks throughout the assembly and reconditioning process * Maintain and organize tools, equipment, and workstations * Follow safety protocols and company procedures to ensure a secure working environment * Assist in inventory management of helmet components and supplies * Work collaboratively with the production team to meet deadlines and efficiency goals *Qualifications & Skills:* * Previous experience in assembly, manufacturing, or a similar technical role is preferred * Strong attention to detail and ability to work with small components * Basic mechanical skills and familiarity with hand tools * Ability to stand for extended periods and perform repetitive tasks * Understanding of safety standards and quality control procedures * Good communication skills and the ability to work in a team environment * Football experience is a plus *Benefits:* * Opportunities for training and career growth * Exciting culture with the fastest growing sports equipment company Please apply directly through Indeed. Pay: $19.50 per hour Benefits: * Employee discount * On-the-job training Work Location: In person
*Sol-ti Production Lead* _*Sol-ti is the Highest Velocity Refrigerated Beverage Company in the United States*_ *Sol-ti’s success resides in consistently developing the highest quality Living Beverages backed by our Employee-Owned team that brings energy and excitement into their daily work with a passion for healthy living and sustainability. * *Sol-ti means ‘of the sun’ or ‘you are the sun’. We are committed to helping individuals shine while also preserving the planet with the use of sustainable glass packaging.* _*Career Basics*_ Location: San Diego, CA Industry Type: Manufacturer Category: Operations Beverages: SuperFood Beverages, Wellness Shots, Functional Beverages Employment Type: * Full Time Position * 12 Hour Shifts * Weekends Reports to: Assistant Manager, Juice Production # of Direct Reports: 8-10 _*Position Summary*_ The Production Lead is responsible for overseeing daily production operations for their shift, ensuring efficiency, quality, and safety standards are consistently met. This role acts as a bridge between management and production staffteam, coordinating workflows, resolving issues on the floor, and driving continuous improvement initiatives. _*Career Responsibilities*_ * Following all good manufacturing policies within the facility. * Lead and supervise production team members during assigned shifts * Plan, organize, and monitor daily production schedules to meet targets * Ensure product quality standards and specifications are consistently achieved * Identify and resolve production issues in real time to minimize downtime * Wear and enforce the proper personal protective equipment usage. * Follow proper FiFo protocols. * Help Maintain Accurate Inventory of all production items. * Order all items needed from Arjons DC. * Ability to properly utilize ATP swabs and record results accurately * Properly set up and breakdown Production Run Line. Which includes the following: · Produce Wash accurately Titrated · Produce Elevator · Grinder · Auger · SX-280 Press · Zumex Citrus Extractor · Pulp filtration system · All supporting equipment * Work with maintenance to timely and accurately report equipment issues. Ability to troubleshoot basic issues and provide information to maintenance team. * Ability to follow recipe accurately and complete simple volume calculations Ability to mix base recipes and process according to SOP * Understand and demonstrate proper use of UV system. * Proper CIP/SIP procedures. · UVs · Tanks · Totes · Process Lines · Additional * Train, coach, and mentor team members to improve performance and skills * Enforce safety protocols and maintain a clean, organized work environment * Collaborate with cross-functional teams (quality, maintenance, inventory, packaging, lwarehousing) * Track production metrics and report on performance, output, and efficiency * Maintain proper documentation and ensure compliance with company policies and food safety standards * Complete any additional task Requested by Plant Manager _*Career Requirements/What we ask of you*_ * Ability to stand on your feet for duration of 12 hour shift * Calculate personnel required to meet daily plan and able to adjust accordingly * Evaluations of temporary employees. * Required to manage team breaks and lunches. * Consistent and reliable attendance * Clear communication * Able to lift 50 lbs. _*What we offer you*_ · Employee Equity Incentive Plan · Performance-based bonuses · Health Insurance programs with industry leading contributions towards your premium · Referral Programs and free access to our functional beverages and supplements to enjoy while at work or home · 80 hours of paid time off, two floating holidays and eight paid company holidays. _*Sol-ti Values*_ We each have an inner light. At Sol-ti, we encourage you to Let Yourself Shine while also encouraging others to shine their brightest. We are committed to helping individuals shine through Liquids of Vitality while also preserving the planet with the use of sustainable glass packaging. _*Create the Best Product: Best in Glass*_ Did you know that most of the other beverages on the market use petroleum based single-use plastic packaging? Not only is this harmful to our oceans and landfills, it is also not sustainable. From the start, we have been committed to bottling in glass for purity, people, and the planet. Our unique UV Light Filtration process uses light rays to preserve our liquid without pasteurizing it – eliminating spoilers without pasteurizing it – so you can enjoy organic, Glass Bottled, Living Beverages. _*How to Apply or Inquire for More Information:*_ Email your resume to Veronica Mathiasen, HR Manager, [email protected] Pay: $24.00 - $26.00 per hour Benefits: * Dental insurance * Health insurance * Paid time off * Referral program * Vision insurance Work Location: In person
Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About this role: Perform quality activities to support manufacturing and sustaining of existing products. Provide quality support to appropriate groups: engineering, manufacturing, quality and design assurance, system/services, incoming/line/final inspection and post market, etc. Develop, apply, monitor, measure, document, improve, and communicate quality methodologies from prodcut development through end of life of a product. Work Mode At Boston Scientific, we value collaboration and synergy. This role follows a onsite work model, requiring employees to be in our local office five days per week. Relocation Relocation assistance is not available for this position at this time. VISA Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time Your responsibilities will include: Perform process monitoring using sampling plans to ensure established controls are being followed. Perform sampling inspection on product using visual and mechanical inspection techniques. Inspect labels, including final packaging labels, for legibility and accuracy. Perform shop-floor paperwork review. Enforce good documentation practices in all documents used during product assembly (DHR, forms, test data sheets, records, etc.). Approve and release finished goods once the inspection is complete (Active Release). Perform process assessments to ensure compliance to appropriate Boston Scientific procedures. Oversee Product Builder/Inspectors Visual Assessment Certifications. Initiate, investigate, and assist in generation and completion of NCEPs. Peform analysis for product returns to determine failure root cause Document failure analysis results in appropriate system Perform product return sample preparation including decontamination, product disposition as needed Perform routine lab work i.e. ensuring lab equipment is properly calibrated Comply with assigned responsibilities as per applicable non-conforming material and rework procedures, which may include: a) Segregate and identify non-conforming material, both physically and electronically (non-conforming material control). b) Execute re-evaluation activities on reworked product. Verify returned material to BSN. Review Return Goods per company procedures. Identify, prioritize and resolve quality issues identified by metrics. Identify and lead departmental initiatives related to best quality practices and continuous improvement. Assist the quality supervisor or other departments in specific tasks (e.g. investigations). Perform “special” quality initiatives using written guidance. Required qualifications: 2-4 Years with High School Diploma and/or Equivalent experience, training , or apprenticeships Requisition ID: 627132 Minimum Salary: $ 56576 Maximum Salary: $ 96200 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
SUMMARY Overview of the position Do you have a passion for writing and entertainment properties? Do you enjoy content from DC? Entertainment – Copy Editor uses their passion for all things DC and other entertainment properties to write and edit copy for trading cards and digital products. ESSENTIAL DUTIES AND RESPONSIBILITIES The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned. Write Entertainment Trading Card, copy within InDesign. Edit and proof copy to ensure accuracy. Stay up to date on pop culture developments, including (but not limited to) DC films/series and comics. Work closely with your fellow entertainment writers to establish and refine agreements for how different properties and subjects/characters are written about. An ability to adapt to the changing guidelines of licensors and vendors. Research characters and storylines across different mediums (i.e. comics, films, tv shows, approved online sources, books, and client provided resources) Works under immediate supervision while exercising reasonable discretion and independent judgment. Communicate with team lead/other departments when issues arise. Hands-on, energetic and motivated self-starter with the ability to work additional hours as required. INTERACTION The position works with Product Development Coordinators, Project Managers and Brand Managers to ensure that Upper Deck products are top quality. EDUCATION/YEARS EXPERIENCE High School Diploma or equivalent. College Degree in Journalism, English, or Communications related is a plus. 1+ year of experience in professional writing or a related area. REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. KNOWLEDGE, SKILLS AND ABILITIES Familiar with DC comics/movies. But most importantly, an openness to always learn more. Demonstrates a willingness to learn, a natural curiosity, and research skills to take on new entertainment properties in a fast-paced environment. Knowledge of trading cards and trading card game industry a plus. Proficiency in MS Office. Previous knowledge of using InDesign preferred. An understanding of AP Style. Strong organizational, editing, communication, and proofreading skills. A self-starter who takes initiative and is always willing to jump into their next assignment. Effective organizational skills with the ability to handle multiple high-priority projects with dedicated attention to detail. Professional demeanor; team player. Ability to interface with internal parties at all levels. Ability to maintain flexible work hours. Work hours are mostly consistent, but flexible working hours may be required based on production requirements. Strong oral and written communication skills. Limited Travel on behalf of the Company, with local convention attendance. A self-starter who takes initiative and is always willing to jump into their next assignment. Effective organizational skills with the ability to handle multiple high-priority projects with dedicated attention to detail. Professional demeanor; team player. Ability to interface with internal parties at all levels. Ability to maintain flexible work hours. Work hours are mostly consistent, but flexible working hours may be required based on production requirements. Strong oral and written communication skills. Limited Travel on behalf of the Company, with local convention attendance.
Position Summary/ Objective: Under the direction of the Housekeeping Supervisor and/or Manager, the Room Attendant will be responsible for providing superb hospitality by maintaining the interior areas of the resort property. Associate will work independently or in a team under little to no supervision. This position relies on good 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. Clean all rooms in accordance with resort standards for cleanliness and efficiency. Maintain work carts/stations as necessary to optimize appearance and efficiency. Remove used linens, towels, necessary products and supplies, and replace with all new items. Clean all areas of kitchens, bathrooms, bedrooms and living rooms as set forth in housekeeping checklists. Vacuum, mop, wash, dispose trash, dust, polish and scrub as needed. Maintain uniforms and nametag. Assist with any special projects as assigned by Supervisor. Communicate effectively with guests, supervisors and associates. Stay informed with emergency procedures, current projects, security issues, and the location of emergency equipment. 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. 0 – 2 years of related experience. High school diploma or equivalent preferred. Ability to multitask effectively. Strong customer service skills. Excellent communication and organizational skills. 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. Fluency in English is preferred. 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.
Omni La Costa Resort & Spa is now hiring Part-Time Camp Counselors to join our team for the Summer Season. This position is ideal for energetic, responsible individuals who enjoy working with children and creating fun, safe, and memorable experiences in a resort environment. If you enjoy working with children and want to be part of an exciting summer program at a world-class resort, we encourage you to apply and join the Omni La Costa camp team! Compensation: $20.00 - $29.00 BOE Position Summary: Responsible for supervising campers and assisting in tennis & recitational activities. Essential Duties: Assisting with tennis & recreational activities for children aged 4 - 16. Lead small or large groups conducting tennis drills, tennis games and various other camp exercises. Monitor campers to identify and respond to unruly behavior or deviations from camp guidelines. Follow policies for the safety of campers, equipment, and personal property. Act as a role model for campers in activities which require cleanliness, punctuality, and sportsmanship. Mediate disputes or conflicts between campers to ensure a peaceful environment. May assist teaching tennis clinics, lessons and regular programming outside of camp hours. Performs other duties as required/needed. Education and Training: Tennis experience required. Previous experience working with children preferred. Leadership Skills: Camp counselors are able to direct and coordinate children during summer camp. Physical Demands: Frequently stands and uses hands; reaches with hands and arms, talks or hears. Regularly walks, sits, climbs, balances, stoops, kneels, crawls or crouches. Regularly lifts up to 10 pounds and occasionally lifts up to 50 pounds. Environment/Noise: Occasionally works in outdoor weather conditions. Noise level is moderate. Certificates/Licenses: None Required. Job Knowledge, Skill, and Ability Preferences: Ability to read and speak English may be required in order to perform the duties of the job (e.g. the associates may be required to communicate with English speaking customers or co-workers, the manuals for the equipment the associates may use are in English). This job description is not an exclusive or exhaustive list of all job functions that an associate in this position may be asked to perform from time to time.
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! ASSOCIATE DIRECTOR, CLINICAL DEVELOPMENT NEUROLOGY The Associate Director provides clinical development support to one or more Project Teams to ensure the successful design, implementation, and execution of development plans for Ionis assets. Major areas of responsibility include: Designing, or assisting with the design of, Ionis-sponsored clinical trials and natural history studies; executing those studies in collaboration with the cross-functional team Identifying translational medicine needs (target engagement assays, biomarkers, natural history studies, etc.) and creating development plans to enable successful clinical development Analyzing and interpreting data from clinical trials and natural history studies Engaging internal and external stakeholders (key opinion leaders, advocacy organizations, etc.) to obtain advice and feedback on development plans, study designs, and study results Communicating project information and plans to the cross-functional team and Ionis leadership Contributing to regulatory submissions, publications, and presentations This position will be in the neurology franchise. Responsibilities: Contribute to design and execution of clinical studies in collaboration with the cross functional team and external medical/scientific advisors, thought leaders and clinical investigators Manage clinical development activities during study conduct. Facilitate conduct of clinical studies by: Performing ongoing review and analyses of clinical study data in conjunction with cross functional team Leading cross functional readiness to ensure timely, high-quality clinical data to meet internal data needs and enable program-level decision making Developing and maintaining excellent working relationships with investigators and study team Delivering high quality scientific presentations on company technology, investigational agents, and/or clinical study issues to investigators and clinical site staff Providing guidance and/or training for external personnel involved in Ionis’ clinical studies Leading and maintaining development of cross-functional risk assessment tool to enable risk-based quality management in Ionis’ clinical studies Contribute to integrated clinical development plans outlining development pathway and evidence required from clinical trials to achieve regulatory approval and market access Develop and implement plans to address translational medicine needs and enable successful clinical trials. Collaborate with cross-functional team, external medical/scientific advisers and opinion leaders on target engagement assay development, identification and analysis of biomarkers, analysis of data (natural history, real-world) to inform clinical trial design, and design and execution of natural history studies Engage regulatory agencies, in concert with the Regulatory Affairs Department and cross-functional team, to design novel and efficient clinical programs Lead/contribute to the writing/review of clinical documents for regulatory submission (study protocols, Investigator Brochures, IND submissions, Clinical Study Reports, etc.) Lead action-oriented development team meetings and periodic project reviews including setting appropriate agendas and approving actionable minutes Identify emerging risks and manage them with the team as appropriate Lead/contribute to preparation of clinical study manuscripts, posters and presentations Maintain clinical and technical expertise in the therapeutic area(s); review scientific journals, attend scientific and key technical meetings Assist in accomplishing department and corporate objectives Other duties as assigned Requirements: PhD in a scientific field with 5+ years’ work experience in the biopharmaceutical industry. Preference will be given to candidates with direct experience working as a clinical scientist in Phase 2 or Phase 3 trials. Ability to successfully work in a cross-functional environment and create strategic development plans for assets entering clinical trials. Ability to take a proactive and hands-on approach to efficiently operationalize plans is imperative. Demonstrated record of executing clinical studies is expected; experience in designing, planning, and executing clinical trials and/or natural history studies is highly desirable Experience providing leadership and guidance to cross-functional project teams Experience in neurology, rare diseases and/or pediatrics is preferred Experience in innovative clinical trial designs is highly desirable A strong basic science background is highly desirable Elevated interpersonal and communication skills with ability to flexibly relate to both internal and external stakeholders. Ability to develop strong positive relationships with colleagues in Development, Research, and senior management. Ability to work on multiple programs and thrive in a fast-paced, innovative environment Attention to detail and quality while also being aware of the need to make timely decisions and to execute Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS004009 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits The pay scale for this position is $165,000 to $215,000 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
Carlsbad, United States of America | Full time | Field-based | R1537588 Job available in additional locations IQVIA is hiring Senior Clinical Research Associate 1 with experience in either oncology, cardiovascular, renal, metabolic, CNS, Obesity (GLP-1), diabetes, GI, MASH/NASH, dermatology, or respiratory: Job Overview: Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Key Responsibilities: • Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. Responsibilities Essential Functions • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications: • Bachelor's Degree in scientific discipline or health care preferred. • Requires at least 2 years of year of on-site monitoring experience. • Equivalent combination of education, training and experience may be accepted in lieu of degree. • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. • Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Good therapeutic and protocol knowledge as provided in company training. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $101,600.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Carlsbad, United States of America | Full time | Field-based | R1537623 Job available in additional locations IQVIA is hiring Clinical Research Associates (CRA) at the CRA 2 level. Ideal candidates will have 1-2 years of onsite monitoring experience with expertise in Cardiovascular/Renal/Metabolic, Oncology, and/or Neurology. Candidates can be located anywhere in the US. Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. • Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability. • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. • Collaborate and liaise with study team members for project execution support as appropriate. • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications • Bachelor's Degree Degree in scientific discipline or health care preferred. Req • Equivalent combination of education, training and experience may be accepted in lieu of degree. • Some organizations require completion of CRA training program or prior monitoring experience. • Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines). • Good therapeutic and protocol knowledge as provided in company training. • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). • Written and verbal communication skills including good command of English language. • Organizational and problem-solving skills. • Effective time and financial management skills. • Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Who Are We? At MagnaFlow, we don’t just build exhaust and emission systems—we define them. With over 40 years of innovation and a legacy of delivering unmatched quality, power, and sound, MagnaFlow is the global leader that champions performance, precision, and style. Our cutting-edge technology, expert craftsmanship, and seamless design make us the ultimate choice for racing legends, performance enthusiasts, and top-tier builders around the world. From performance exhausts to suspension products, we create solutions that embody courage and innovation. Trusted by icons like Mario Andretti, Chip Foose, Joey Logano, and Leah Pruett, we’re the name behind the roar of champions. At MagnaFlow, it’s not just about driving—it’s about driving greatness. We are seeking a motivated and detail-oriented Marketing Intern to support a wide range of marketing and event-related functions. This role is ideal for someone looking to gain hands-on experience in project coordination, event preparation, brand execution, and general marketing operations. You’ll assist the team in organizing materials, preparing for upcoming shows and activations, and supporting initiatives that strengthen brand awareness and operational efficiency. Responsibilities: Conduct market, competitor, and industry research to support planning and strategy. Assist with pre-event planning, including gathering materials, organizing inventory, and preparing event collateral. Help coordinate logistics for trade shows, displays, and internal/external activations. Assist with organizing and maintaining marketing assets and shared resources. Support product launches by preparing collateral and tracking deliverables. Assist with Consumer Sponsorship program maintenance and management including asset delivery and follow-ups Support on-site event execution, including operations and brand presentation when required. Requirements Currently pursuing a degree in Marketing, Business, Communications, or a related field (or recent graduate). Strong organizational skills with high attention to detail and accuracy. Clear written and verbal communication abilities. Interest in event planning, brand activations, and operational marketing. Proficiency with Microsoft Office; experience with Canva or Adobe tools is a plus but not required. Ability to work independently and collaboratively in a fast-paced environment. Proactive, reliable, and willing to roll up your sleeves when needed. Willingness to work occasional evenings or weekends to support events and brand activations, as required.