- Kelly Services (Petaluma, CA)
- …+ Participate in internal/external audits and ensure regulatory adherence (GMP, FDA ). **Qualifications:** + Bachelor's or Master's degree in Microbiology, Biology, ... Biosafety Level 1 and 2 laboratory protocols. + Knowledge of GMP and FDA regulations as applied to microbiology labs. + Hands-on experience running and maintaining… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Maintains research practices using Good… more
- Charles River Laboratories (Northridge, CA)
- …such as Standard Operation Procedure manuals, Current Good Manufacturing Practices, FDA and AABB regulations. **Job Qualifications** * High school diploma or ... supported the development of 100% of the current commercially available FDA -approved immunocellular therapies. Our mission is to provide a best-in-class portfolio… more
- UCLA Health (West Hills, CA)
- …bodies including The Joint Commission, California Board of Pharmacy, CDPH, DEA, and FDA At UCLA Health, dedicated professionals like you have helped make us one ... compounding environments + Experience ensuring compliance with The Joint Commission, DEA, FDA , CDPH, and California Board of Pharmacy standards + Competence in… more
- Cedars-Sinai (Los Angeles, CA)
- …source documents to ensure that research is being conducted according to IRB, FDA , OHRP, HIPAA and other agency guidelines. + Maintains high quality, up-to-date ... regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies. + Completes appropriate IRB… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …understanding of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory ... etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for… more
- Teleflex (Pleasanton, CA)
- …skills. * Familiarity with ISO 13485, ISO 62304, ISO 14971, IEC 82304-1, MDD, and FDA QSR. * Experience developing mechatronic products with IEC 60601 is a plus. * ... the marketplace. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations,… more
- Deloitte (San Francisco, CA)
- …Compliance: Ensure all solutions and processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and industry best practices. + Data Analysis & Reporting: ... (Word, Excel, Power Point) + Knowledge of global regulations and guidelines such as ICH, FDA , EMA, PMDA, etc. + Ability to travel 50%, on average, based on the work… more
- University of Southern California (Los Angeles, CA)
- …ongoing assessment of protocol deviations and violations.4. Participates in NCI, FDA and pharmaceutical audits and is knowledgeable of their regulations, especially ... are recorded correctly and accurately. If Serious Adverse Events are experienced, follows FDA guidelines for prompt reporting within 24 hours. e. If requested will… more
- Charles River Laboratories (Northridge, CA)
- …supported the development of 100% of the current commercially available FDA -approved immunocellular therapies. Our mission is to provide a best-in-class portfolio ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more