- Repligen (Waltham, MA)
- …with eQMS systems or digital audit tools Familiarity with regulatory standards ( FDA , GMP , etc.). Excellent communication, negotiation, and interpersonal skills. ... OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality , compliance, and… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …phase and/or late phase drug product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge ... of FDA , ICH, and other regulatory requirements for CMC.- Strong...for CMC.- Strong understanding of integration and partnering with Quality , Regulatory, Operations, Non-clinical, Clinical, and other functional areas.Demonstrated… 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
- Coregistics (Elgin, IL)
- …in a food manufacturing environment. + Familiarity with food safety standards (HACCP, GMP , FDA , USDA) and quality assurance practices. + Proficiency ... Quality Inspector/Technician Elgin, IL (http://maps.google.com/maps?q=Elgin+IL+USA+60123) Description The QA...to ensure compliance with food safety regulations and company quality standards. This position works closely with production teams… more
- Sanofi Group (Morristown, NJ)
- …science, or equivalent + Experience preparing for and direct support of US FDA GMP Pre-Approval Inspections, and follow up activities (eg, inspection response ... **Job Title:** Global Quality Lead, GMP , GDP Audit and...+ Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products… more
- Sanofi Group (Framingham, MA)
- …Quality . . **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing of US FDA inspection findings and best ... was possible. Ready to get started? **Main Responsibilities:** . **Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up** for US… more
- Caris Life Sciences (Phoenix, AZ)
- …manufacturing or a related product environment. + Familiar with ISO13485, ISO9001, and FDA regulations/requirements. + Familiar with GAMP5 and GMP principles. + ... than yourself, Caris is where your impact begins.** **Position Summary** The GMP Engineering Supervisor is responsible for assisting in company-wide compliance to… more
- Aerotek (Nashville, TN)
- **Job Title: GMP Quality Technician** **Job Description** As a GMP Quality Technician, you will be responsible for performing visual inspections within ... of IV bags and vials meets specified requirements and quality standards. This position requires previous experience in ...Here?** Join a new medical manufacturing facility that is FDA regulated and part of a significant expansion project.… more
- ThermoFisher Scientific (Cincinnati, OH)
- …cancer. **How will you make an impact?** Investigates and observes Operations and Quality Operations departments to assure that FDA current Good Manufacturing ... in accordance with the Code of Federal Regulations. Assists the Operations and Quality Operations departments in satisfying all FDA and DEA requirements. **What… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …health authorities (eg FDA , EMA, MHRA, etc.) + Excel in a quality driven organization + Have an understanding of biologics manufacturing operations To be ... We are currently looking to fill an Associate Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Principal : 8+ years of professional experience or equivalent in pharmaceutical/ FDA -regulated environments such as data management, quality assurance, ... The Principal GMP Data Integrity Policy Specialist is essential in...solutions, and lead DI remediation activities per the DI Quality Plan. + Provide expertise and support in developing… more
- Aerotek (Chaska, MN)
- …people + Champion career development and strategic training plans + Ensure compliance with FDA QSR, GMP , and internal quality standards + Drive continuous ... Office (Word, Excel, PowerPoint) and Windows OS + Experience in regulated industries ( FDA preferred) + Certified Practitioner in DBS tools (Standard Work, QSB, TPI)… more
- ThermoFisher Scientific (Middleton, WI)
- …(Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Laboratory Setting, Office **Job Description** At Thermo ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
- ThermoFisher Scientific (Middleton, WI)
- …**Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
- Conagra (Indianapolis, IN)
- …and processes. You will need a sound knowledge of product types, department rules, GMP 's, FDA , OSHA, Safety, Quality and technical skills relative to ... Defect Handling, Planning/Scheduling etc. + You will improve 5S, housekeeping and GMP , in relation to tools, shop safety and equipment repair. **QUALIFICATIONS:**… more
