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cgmp in_process_testing stability_testing

๐Ÿ“‹ 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.

๐ŸŽฏ 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.

๐ŸŽ 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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