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Posted: Tuesday, September 5, 2017 5:59 PM

Position: Quality Associate - GxPLocation: Foster City, CAType: ContractResponsibilities: Maintain QA and cGxP compliance for all aspects Write, review, approve, and maintain cGxP documentation for Quality Systems functions (SOPs, protocols, technical reports, etc.) Follow Standard Operation Procedures for global Quality Interact with QA during routine team meetings and on technology transfer projects Direct batch record review and lot disposition activities to ensure release of lots within prescribed timelines and in compliance with applicable Company policies and Client Quality Agreements Support equipment, utility and facility qualification activities through review and approval of qualification documents and deliverables, as needed Review and approve analytical method qualifications strategy and protocols and reports, as needed Maintain all GMP documentation, using Good Documentation Practices With help of Management, incumbent will prioritize, schedule and manage multiple projects and resources simultaneously Minimum of 3 years in Pharmaceutical Quality Assurance, preferably in the biologics field Experience in reviewing cGMP/GLP related documents (SOPs, protocols, batch records, technical reports, etc.) Working knowledge of cGMP principles with respect to FDA and EMA regulations Working knowledge of cGCP and cGTP a plus - provided by DiceGXPHARMA


• Location: Foster City, San Mateo

• Post ID: 81330517 sanmateo is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017