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Analyst, QC III

Marin Metro Area, CA

Posted: 06/14/2019 Job Type: Scientific Job Number: JN -062019-25076
  • Develop framework for critical materials management including inventory and documentation management.
  • Support and develop statistical trending processes for stability, lot release and reference standard results.
  • Create and/or revise SOPs.
  • Initiate and investigate deviations and CAPAs in validated system (e.g. Trackwise).
  • Support GMP activities including regulatory agency audits and LIMS data management.
  • Understanding of critical material management in GMP QC setting.
  • Understanding of reference standard management which includes both qualification and inventory management.
  • Excellent knowledge of GMPs.
  • Experience with regulatory agency audits.
  • Experience with LIMS for data management and Trackwise for deviation/CAPA management.
  • Experience in statistical trending of stability, lot release and reference standard data.
  • Understanding of ICH guidances especially Q1E.
  • Team player and work in collaboration with various groups within and outside QC.
  • B.S and/or M.S. in Biology or Biochemistry or similar field.
  • 3-5 years of GMP experience.
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