- Charles River Laboratories (Northridge, CA)
- …help you build a career that you can feel passionate about. **Job Summary** The GMP Account Specialist is responsible for driving commercial success of the GMP ... * Own the sales and marketing strategy for the GMP portfolio; drive execution to meet growth targets and...areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …evolution initiatives, and will support implementation in internal and external GMP facilities. **Key Responsibilities:** + Plan and execute cell culture process ... development laboratory studies and support process implementation in internal and external GMP facilities. + Provide technical support for GMP operations. +… more
- Edwards Lifesciences (Irvine, CA)
- …+ Maintain expertise in current and emerging GMP , GLP and FDA QSR requirements, quality trends, and international regulatory compliance standards. Interpret ... Business Unit and Global Supply Chain partners. + Knowledge of US FDA Quality System Regulations, ISO 13485, ISO 14971, and other applicable global regulatory… more
- Element Materials Technology (Concord, CA)
- …and regulatory requirements as applicable ie ISO/IEC 17025:2017, USP, GMP , FDA , and ICH guidelines. The ** Quality Manager** monitors and advises on ... **Overview** Element is currently seeking a ** Quality Manager** to join our growing team in...requires 5 year of pharmaceutical/biotechnology industry experience in a GMP environment and 2 years of supervisory experience. +… more
- AbbVie (Irvine, CA)
- …including computerized systems, used within the R&D laboratory function associated with FDA Good Manufacturing Practices ( GMP ) testing for biological and small ... with established guidelines for pharmaceutical products manufactured in a GMP environment. + Utilize knowledge of GMP ...a GMP environment. + Utilize knowledge of GMP concepts relating to Pharmaceutical manufacturing environment to plan,… more
- Praxair, Inc - a Linde Company (Fresno, CA)
- …assigned locations in training Managers, supervisors and personnel on Company and FDA GMP procedures + Audit/Assess assigned LG&E manufacturing and warehousing ... Quality personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure … more
- Actalent (Santa Ana, CA)
- …related field or comparable additional experience. Associates okay with 2 years of FDA quality experience, Bachelors at least 1 year. Pharmaceutical experience ... up with office and lab personnel on documentation. Skills Gmp , Quality assurance, batch record review, Capa,...preferred FDA /cGMP Experience - 1 year Experience with Microsoft office… more
- Abbott (Temecula, CA)
- …experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA , GMP , and ISO 13485 + Solid communication and interpersonal skills. ... diversity, working mothers, female executives, and scientists. **The Opportunity** **The Sr, Quality Engineer position works onsite of our Temecula, CA location in… more
- Fortive Corporation (Irvine, CA)
- …PQ validation** for facility, automation, and process systems. + Ensure compliance with ** FDA , EMA, GMP , OSHA, and safety regulations** . + Support **regulatory ... operations, engineering, automation systems, and process improvements** in a ** GMP -regulated manufacturing environment** . This role ensures **compliance, efficiency,… more
- LGC Group (Petaluma, CA)
- …processes: Change Control, Audits, CAPAs, Deviations, and QA reporting and approval of GMP documentation. + Quality Operations: Support the following quality ... and Berlin, Germany. Job Description Roles and Responsibilities + Quality & Compliance: Complete all activities adhering strictly to...Audits, CAPAs, Deviations, and QA reporting and approval of GMP documentation + Other Duties as mandated by site… more