Quality Assurance Manager, BIO/GLP
Posted on: November 18, 2021
Job OverviewJob Order: JO000124180Date Posted:
10/12/2021Salary:Industry:Metro Area: Hayward, CAStart Date:Quality
Assurance Manager, BIO/GLPAt SRG, we create meaningful connections
that empower individuals and businesses to shape tomorrow?s
world.Working as part of the SRG team, you will work with our
client which are Pharmaceutical or Bio-Pharmaceutical companies to
ensure work quality and accuracy for our client in the Bio
Pharmaceutical Industry. The Quality Assurance Manager, BIO/GLP
will implement, maintain and enhance quality procedures and systems
to ensure compliance with US FDA, OECD, and ICH regulatory
requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part
320, and other relevant guidances and publications.Role &
- Assist the quality sr. leadership with client audits /
regulatory inspections and as back-up in their absence
- Assist with client RFIs and requests
- Assist quality sr. leadership with audit internal, external
- Conduct QA audits of bioanalytical laboratories and functions
including but not limited to: ongoing process, data review audits,
technical report, and study independent facility / process.
- Provide input to method, equipment, computer validation
- Maintain GLP Master Schedule.
- Maintain appropriately detailed notes, audit reports, and
- Provide input to documentation and data storage systems.
- Ensure that requirements and documentation for all GLP systems
are kept current according to ever-changing guidelines and industry
- Provide GLP training to staff as necessary.
- Effectively report quality issues to supervisor, Study
Director, and Frontage management, as appropriate.
- Provide oversight and input to analytical and process
investigations, CAPA and calibration programs, specifications, and
supplier selection processes.
- Conduct outside vendor audits as may be required, including
contract laboratories and raw material suppliers; resolve and
follow-through on any quality issues.
- Review and maintain up-to-date Standard Operating Procedures
- BS in Chemistry, or other related discipline
- Five (5) years of relevant experience in the pharma industrySRG
is an Equal Opportunity Employer - All qualified applicants will
receive consideration without regard to race, color, religion,
gender, national origin, age, disability, veteran status, or any
other factor determined to be unlawful under applicable law.
Keywords: SRG, Hayward , Quality Assurance Manager, BIO/GLP, Executive , Hayward, California
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