- Merck & Co. (Durham, NC)
- …selected candidate will participate in equipment validation, process validation, and GMP laboratory readiness.- The Quality Operations Laboratory Specialist ... ingredient, finished product, and laboratory testing for the BCG vaccine.The Specialist, Quality Control participates in a team of analysts in the development,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …clinical quality , or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals.Experience in ... seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of ... is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in… more
- Eisai, Inc (Raleigh, NC)
- …of combination products and/or Biologics is a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record ... investigation and resolution, as applicable) .Familiarity with applicable regulatory requirements (eg, FDA , EMA, ICH) and quality systems.Strong oral and written… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …ensure operational efficiencies and successful production of API onsite. Prior experience in a GMP environment or life science industry is a plus for this role. This ... for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the...and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …devices, circuits, and switchgear used in cGMP and non GMP systemsInvestigate, troubleshoot, and provide repairs to equipment, instruments, instrumentation ... with all company and/or site policies and proceduresSupport maintenance driven quality events including but not limited to Deviations/Investigations, Out of… more
- Actalent (Hartland, WI)
- …cross-functionally with production. Verbal communication skills. Experience with quality inspection, quality auditing, FDA inspections, GMP , FDA . ... inspections and batch record information, and ensuring compliance with GMPs, SOPs, FDA regulations, and quality processes. Responsibilities Perform quality … more
- ProCaps Labs (Henderson, NV)
- …Partner with the Quality Control team to ensure compliance with GMP , FDA , and industry standards. Investigate and resolve production issues, implementing ... in soap or chocolate manufacturing. Technical & Leadership Skills: Strong knowledge of GMP , FDA regulations, and quality systems related to food or drug… more
- MEITHEAL PHARMACEUTICALS INC (Chicago, IL)
- …challenging QA experience in the pharmaceutical industry; excellent knowledge of current GMP as well as FDA trends and guidelines; strong interpersonal ... currently markets over 60 US Food and Drug Administration ( FDA )-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive… more
- Nestle Operational Services Worldwide SA (Gaffney, SC)
- …under the general direction and guidance of the QA Supervisor. The Quality /Lab Technician is responsible for specific activities, as described below, relative to ... incidents Has read and understands the Safety, Health and Environmental Policy Quality : Follow recipes and deviations at all times. Unauthorized deviations are… more
- Omega Medical Imaging LLC (Sanford, FL)
- …II electromechanical medical devices, preferably with software. Proven track record navigating FDA GMP /QSR, 510(k) submissions, CE Mark, and ISO 13485. Strong ... Omega Medical Imaging is the world leader in FDA -cleared interventional X-ray systems with cutting-edge AI-driven radiation reduction technology. We're passionate… more
- AEROTEK (Elgin, IL)
- …raw ingredients Experience in food safety or quality control Knowledge of HACCP, GMP , FDA , and USDA standards Familiarity with quality control testing ... team performance, optimize production processes, and uphold the highest standards of quality and safety. From coaching and training to troubleshooting and reporting,… more
- Medtronic (Billerica, MA)
- …(MES, ERP, Labeling, Quality , Maintenance.) Background in regulated environments (eg, FDA , GMP , ISO) Financial acumen, including IT budget oversight Proven ... on-budget delivery of IT projects and strategic programs with first-time quality . Support critical manufacturing applications in collaboration with Apps COE's (ERP,… more
- Cedent (Brecksville, OH)
- …duties may be assigned. Prepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies, including FDA , Notified ... Files. Create and/or modify regulatory procedures to remain in compliance with FDA , ISO, European, Canadian, and other standards. Work with the international… more
- Michael Page (Skokie, IL)
- …Compliance Oversight: Ensure all products comply with applicable regulations and standards, including FDA (21 CFR), FSMA, DSHEA, GMP , FTC, Health Canada, EFSA, ... (Master's or RAC certification is a plus). Additional certifications or training in FDA regulations, GMP , HACCP, or international regulatory standards (eg, ISO,… more
- Kerry (Fort Worth, TX)
- …all food production activities comply with current food safety laws and guidelines (BRC, FDA , USDA). o Conduct regular GMP inspections, Glass and Brittle plastic ... benefits and incentives are subject to eligibility requirements). Key responsibilities As a Quality Assurance Technician for RTE foods, you will play a crucial role… more
- Amylyx Pharmaceuticals (Cambridge, MA)
- …(experience with JMP and/or other statistical software preferred) Experience managing external GMP quality control teamsat manufacturing and testing partners a ... read the opportunity below and apply. THE OPPORTUNITY The Quality team is expanding and looking to hire a...and commercial supply of drug product. Support of QC GMP systems including maintaining the reference standard and critical… more
- Steris Corporation (Minneapolis, MN)
- …and service solutions around the globe. Position Summary The Senior Product Quality Engineer is responsible for managing processes and leading projects to maintain ... and improve the quality system in accordance with the requirements of, as...the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other… more
- Lucky Vitamin (Bloomingdale, IL)
- …among all shifts. Recommends measures to improve production methods, equipment performance, and quality of product. Monitors product quality and works with ... Quality to ensure specifications are met. Monitors quality control as needed to determine that all products and packaging are neat, clean, and correctly packed… more