Analyst, QC III
300 Bel Marin Keys Boulevard Novato, CA 94949
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.
- 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.