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cgmp in_process_testing stability_testing๐ Description
- Review analytical data for release, stability & in-process testing at CMOs.
- Oversee labs; investigate out-of-spec, out-of-trend, deviations.
- Follow up with labs to correct deficiencies in test packages.
- Submit test packages to QA; load data into the electronic storage program.
- Review data for reference standard qualification, method validation & transfer.
- Travel as needed to analytical testing sites.
๐ฏ Requirements
- M.S./B.S. in life sciences; Chemistry/Analytical Chemistry preferred.
- 5+ years in Quality Control in pharma; cGMP; 2+ years management.
- Strong analytical skills; ability to work independently under deadlines; detail-oriented.
- Sophisticated understanding of cGMP; distinguish regulated vs non-regulated activities.
- Ability to communicate with vendors on project scope, results and updates.
๐ Benefits
- Market-leading compensation
- 401K with employer match on first 3% and 50% on next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award
- Comprehensive health care with premiums covered
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