Quality Associate GxP - Foster City, CA | Biospace
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Quality Associate GxP

I.T. Solutions, Inc.

Location:
Foster City, CA
Posted Date:
9/12/2017
Position Type:
Consultant, Contract
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

•   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

Requirements

•   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