- Kelly Services (Oklahoma City, OK)
- …projects. + Familiarity with deviation and CAPA processes. + Strong understanding of GMP regulations ( FDA , EU, etc.). + Excellent writing, editing, and ... **Tech** **nical** **Writer ( GMP )** **Batch Record Review & Deviation Investigation** **Location**...CAPA documentation. + Ensure documentation is in compliance with FDA , EU, and other regulatory standards. + Support the… more
- BioFire Diagnostics, LLC. (Lombard, IL)
- …Minimum of 1 year of experience in training development, ideally in an FDA -regulated setting. + Instructional design or GMP -related certifications are preferred. ... The GMP Training Specialist plays a pivotal role in...all shifts. This role focuses on maintaining compliance with FDA , ISO 13485, ISO 9001, ISO 14001, and ISO… more
- Eastman Kodak Company (Rochester, NY)
- …Chemistry, Engineering, or related technical field AND 1-5 years of experience in a FDA / GMP regulated laboratory. * Or - Laboratory Analyst - Associates or ... Engineering, or related technical field AND 0-3 years of experience in a FDA / GMP regulated laboratory. * Proficient in computer office platforms such as MS… more
- Randstad US (North Billerica, MA)
- …raw materials and finished goods while maintaining product/lot segregation in compliance with FDA and cGMP guidelines. Skills + GMP + Material Handling ... gmp material handler. + north billerica , massachusetts + posted november 8, 2024 **job details** summary + $25 - $28 per hour + temp to perm + associate degree +… more
- Amgen (Washington, DC)
- …and data quality management while ensuring compliance with industry regulations, such as GMP /GxP and FDA requirements. This role will impart a deep understanding ... Compliance:** Ensure all master data practices meet global regulatory standards, including FDA , EMA, GMP , and other pharmaceutical industry regulations. +… more
- Keurig Dr Pepper (Sacramento, CA)
- …the facility to ensure that the plant is fully operating in compliance with FSMA, FDA GMP , OSHA, EPA regulations and GFSI guidelines. + Lead the root cause ... defined by FSMA, six sigma Quality performance, and 100% compliance to all FDA , EPA and OSHA regulations. **Location:** This position is located at our Sacramento,… more
- Catalent Pharma Solutions (Harmans, MD)
- …in Pharma/Biotech or other cGMP manufacturing environment required + Knowledge of GMP 's, FDA regulations and documentation procedures required + Proficient ... **Supervisor, Manufacturing** **Summary:** _Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus.… more
- System One (Allentown, PA)
- …will be driving business changes, maintain a positive company culture and enforcing FDA GMP regulations. Responsibilities: + Planning, directing and managing all ... reports of Managers and Leads as well as indirect reports + Expert in FDA GMP regulations #M3 #LI-GS1 System One, and its subsidiaries including Joule, ALTA IT… more
- Unither Pharmaceuticals (Rochester, NY)
- …other regulated environment; or equivalent combination of education and experience, preferably FDA / GMP KNOWLEDGE SKILLS & ABILITIES: + Strong, proven leadership, ... on the process and any process changes. Culture of GMP Compliance & Safety (20%) + Follows all ...GMP Compliance & Safety (20%) + Follows all GMP and HSSE rules and regulations. Accepts accountability for… more
- Envista Holdings Corporation (Pomona, CA)
- …RESPONSIBILITIES** + Other duties may be assigned, in addition to those identified below + Ensures FDA QSR ( GMP ), FDA OTC, ISO 13485, MDD, CMDCAS, MDR, MDSAP ... regulatory requirements and corporate standards. This involves assuring quality standards ( FDA , ISO, CMDCAS, MDD, MDR, MDSAP and Canadian Medical Device… more
- ICU Medical (Salt Lake City, UT)
- …all quality assurance / validation activities according to the applicable guidelines, ie FDA , GMP , ICH etc. Ability to initiate problem-solving and technical ... to measurement protocols and cGMP requirements to comply with FDA standards. Prepares system documentation, including user requirement documents, specification… more
- ICU Medical (Salt Lake City, UT)
- …all quality assurance / validation activities according to the applicable guidelines, ie FDA , GMP , ICH etc. *Ability to initiate problem-solving and technical ... to measurement protocols and cGMP requirements to comply with FDA standards. *Prepares system documentation, including user requirement documents, specification… more
- Fortive Corporation (Irvine, CA)
- …adherence to standard operating procedures (SOPs), safety protocols, and regulatory requirements (eg, FDA , GMP ). + **Lean Six Sigma Implementation:** + Apply FBS ... and equipment qualifications. + Thorough knowledge of regulatory requirements (eg, FDA , GMP ) governing biologics laboratory operations. + Experience with… more
- Whole Foods Market (Thornton, CO)
- …conditions in compliance with applicable health and safety codes, including OSHA, FDA , GMP , and state regulations. Establishes warehouse organization standards, ... in step with all regulatory and safety standards related to SQF, GMP , HACCP, FDA , OSHA, NSF, NOP, and any local/state/federal requirements. + Provides external… more
- ManpowerGroup (Raleigh, NC)
- …on the job and specialized technical training. Strong applied and working knowledge of FDA ; GMP ; GLP; compliance and NIST traceability. Expert knowledge of test ... train on new instrumentation areas and build an understanding of pharmaceutical and FDA requirements. Increased client interaction will occur and the Tech II will… more
- ADM (Decatur, IL)
- …analytical results in a timely matter. + Support and comply to all applicable FDA , GMP , USP, Biosafety, and OSHA requirements. + Follow laboratory standards and ... applications, and software). + Maintain awareness and adhere to all applicable FDA , GMP , USP, Biosafety, OSHA and employer standards and guidelines. + Follow… more
- ThermoFisher Scientific (Milwaukee, WI)
- …decisive actions. Will manage Supplier Quality processes in compliance with ISO 9001/13485, FDA , GMP and other external requirements. The Staff Supplier Quality ... Supplier Quality procedures and processes in compliance with ISO, FDA , GMP and other external requirements. **Key Responsibilities:** **Manage Supplier Issues**… more
- Randstad US (Amityville, NY)
- …is critical in maintaining the highest quality of our products, ensuring compliance with FDA , GMP , and HACCP standards. If you are interested please here and ... internal audits of processes and procedures to ensure compliance with FDA , GMP (Good Manufacturing Practices), and HACCP (Hazard Analysis Critical Control… more
- Abbott (Abbott Park, IL)
- …+ Engineering Systems and Procedures Development and Implementation: Ensure compliance with FDA , GMP , CBER, and all other applicable agency regulations. + ... a manufacturing support role. + Regulatory Experience: Experience in FDA -regulated manufacturing, consumer packaged goods, or similar. + Validation/Commissioning:… more
- Danaher Corporation (Bothell, WA)
- …also possess previous experience in: + Medical Device with ISO 13485:2016 standards, FDA GMP regulations, or healthcare experience. + Using calibrated equipment ... in the Quality department and will contribute to improvements in compliance to FDA 's Quality System Regulation and ISO 13485 Standard. This position will make… more