- Stanford University (Stanford, CA)
- …investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. _* - ... protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. +… more
- ThermoFisher Scientific (Fremont, CA)
- …comprehensive quality assurance measures in compliance with ISO 13485 and FDA regulations. + Drive continuous improvement initiatives by applying PPI methodologies. ... in a cGMP laboratory setting. + In-depth knowledge of ISO 13485 and FDA manufacturing and quality assurance standards. + Strong background in continuous improvement… more
- Owens & Minor (El Segundo, CA)
- …driver's license required. + Must meet job-related requirements to comply with DOT, FDA and standards of accrediting body. + Current MVR must meet company minimum ... Knowledge of warehousing and inventory management + Knowledge of DOT and FDA regulations preferred + Knowledge of Home Healthcare industry preferred **Computer… more
- Cedars-Sinai (Los Angeles, CA)
- …with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **What are the Primary Duties & ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- Cedars-Sinai (Los Angeles, CA)
- …study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- Abbott (Alameda, CA)
- …and maintenance of departmental operating procedures to ensure compliance to relevant FDA , QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate ... experience in Software Quality Assurance and/or Software Testing experience. + Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of… more
- BeOne Medicines (Emeryville, CA)
- …experience with supporting and involvement in GCP inspections (main inspectorates ( FDA , EMA, CFDI etc.,)) and other country specific inspectorates (MFDS, PMDA, ... as required. + Participate in & support GCP, GVP & GLP authority inspections ( FDA , EMA, PMDA, TGA, CFDI etc.,) in assigned roles such as back-room support,… more
- Charles River Laboratories (Hollister, CA)
- …service and compliance documentation as required by company policy, cGMP and FDA . * Responsible for resolving client testing laboratory instrument service issues. ... proudly supported the development of ~85% of the drugs approved by the FDA in 2019. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity… more
- Abbott (Alameda, CA)
- …with complaints investigations in a regulated environment and knowledge of the FDA /QSR regulation and ISO 13485 standard is required. + An understanding of ... an investigation. + Complaints investigations are a primary focus of corporate and FDA audits. + Investigations that are not conducted or documented properly could… more
- Cedars-Sinai (CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary Duties and Responsibilities + ... with all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. + Maintains research practices using Good… more