Analyst, QC III

Novato, CA 94949

Posted: 06/13/2019 Employment Type: Contract Industry: Quality Job Number: 6384

Job Description

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.


  • 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.

Job Requirements


  • 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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