- 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
- Keurig Dr Pepper (Frisco, TX)
- …ensure they are fully operating in compliance with KDP Policy & Procedures, FSMA, FDA GMP , and GFSI guidelines. + Support site incident management (with support ... products as defined by FSMA, six sigma Quality performance and compliance to all FDA , EPA and OSHA regulations and GFSI requirements. Expect up to 50% travel to… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …consumer, and Catalent employee.** **The Role:** + Ensure compliance with all FDA ( GMP / GCP) regulations. Implement standard operating procedures (SOPs) ... that apply to the clinical packaging environment are preferred + GMP and FDA regulated industry experience is required + Demonstrable leadership experience at… 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
- 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
- Actalent (Norwood, MA)
- …equipment. + Ensure that all validation activities comply with regulatory requirements, including FDA , GMP , and ISO standards. + Perform risk assessments and ... + Strong knowledge of validation principles and regulatory requirements ( FDA , GMP , ISO). + Proficiency in developing and executing IQ/OQ/PQ protocols.… 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
- Kelly Services (Jacksonville, FL)
- …non-clinical and clinical lenses. + Maintain accurate documentation to ensure adherence to GMP , FDA and ISO regulations. + Assist technical services in executing ... lenses. + Maintains lot integrity and control to ensure compliance with FDA , GMP , ISO and company requirements. + Solution Preparation and Solution testing. +… 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
- 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
- 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
- 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
- Bausch + Lomb (O'Fallon, MO)
- …in a manufacturing or quality control role. + Basic knowledge and understanding of FDA Regulations and GMP , ISO 9001/ISO 13485 requirements, and Quality System ... + Quality Inspection experience. Manufacturing background desirable. + Working in an FDA / GMP regulated environment to include "Clean Rooms" and all restrictions… more
- Abbott (Plymouth, MN)
- …train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA , GMP and all other applicable agency regulations. + Support all ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… 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
- Fujifilm (College Station, TX)
- …objectives. + Strong understanding of 21 CFR Part 11 and Annex 11 regulations, FDA , GMP , GAMP and ISPE.Develop staff to maximize contributions to the team ... FDBT site to instill a 'Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles. + Act as an… more