- Hologic (San Diego, CA)
- …documentation, including development and notebook studies for operations. + Participates in FDA , ISO lab audits and performs BSL3 audits. + May represent group ... with a minimum of 3-5 years of related experience, ideally in GMP /GDP/GLP environment + Knowledge of Microbiology/Molecular and Chemistry. + Working knowledge of… more
- LGC Group (Petaluma, CA)
- …Change Control, Audits, CAPAs, Deviations, and QA reporting and approval of GMP documentation. + Quality Operations: Support the following quality processes: Change ... Control, Audits, CAPAs, Deviations, and QA reporting and approval of GMP documentation + Other Duties as mandated by site priorities and Quality, Business, or Safety… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …the safe, compliant, and uninterrupted delivery of utilities to our 24/7 commercial GMP biologics manufacturing operations. Success is achieved by leading a team of ... and technicians in the operation, maintenance, repair, and improvement of GMP utility systems, including facility systems (eg, HVAC, electrical), high-purity water… more
- Amgen (Thousand Oaks, CA)
- …R&D and commercialization to the department + Extensive knowledge of GLP and GMP activities + Clearly understands and applies knowledge of regulatory requirements ( ... FDA , ICH, USP, etc.) to completion of projects +...experience with regulatory requirements for API/Product (CMC for IND/NDA, GLP/ GMP , ICH) + Experience in authoring briefing books, investigational… more
- Abbott (Pomona, CA)
- …validated rooms and equipment. **WHAT YOU'LL DO** + Applies basic understanding of FDA , ISO and cGMP theories and principles. + Contribute to Group's objectives by ... and effectiveness of Abbott Quality Management System per ISO, FDA , and other regulatory agencies. + Responsible for exhibiting...other regulations governing medical device assembly and design, eg GMP , QSR, ISO and CMDR. + Understanding of machine… more
- ThermoFisher Scientific (West Hills, CA)
- …(Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail ... the team, process, and systems align with applicable regulations ( FDA , 21 CFR Part 820, Part 11, ISO 13485,...(eg, FMEA). + Support internal and external audits (eg, FDA , Notified Bodies). **Multi-Functional Collaboration** + Partner with R&D… more
- Abbott (Sylmar, CA)
- …requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla. + Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP , IEEE 1012, IEC 62304 and ISO 13485. + Advanced… more
- US Foods (Hawthorne, CA)
- …procedures include: safety guidelines and the use of Good Manufacturing Practices ( GMP 's) and Sanitation Standard Operating Procedures (SSOPs) and must be adhered ... throughout the company in a professional manner . External: USDA/ FDA officials **WORK ENVIRONMENT** . Must be able to.... HACCP Certified preferred. **PREFERRED QUALIFICATIONS** . USDA or FDA experience Preferred Benefits for this role may include… more
- ThermoFisher Scientific (Fremont, CA)
- …lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, ... comprehensive quality assurance measures in compliance with ISO 13485 and FDA regulations. + Drive continuous improvement initiatives by applying PPI methodologies.… more
- AbbVie (Pleasanton, CA)
- …discipline. Must have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s). If experience required, must have 1 ... GD&T + performing daily assigned tasks in compliance with FDA 's Quality System Regulation (QSR), ISO 13485, ISO 14971,...to medical device development life cycles, manufacturing processes & GMP ; & + working in a cross-functional team, in… more