Associate Director, Quality Control Operations, Global Analytics
San Carlos, California, United States
USD 184K-214K Mid-level Full Time
Tasks
- Drive corrective and preventive actions CAPA with stakeholders
- Ensure on time QC testing for raw materials intermediates and drug substance
- Implement analytical strategies for process release and stability testing
- Lead investigations for deviations OOS OOT OOE and lab incidents
- Maintain quality control systems for sampling testing documentation release
- Manage QC data storage retrieval retention and documentation
- Oversee QC method validation and transfer activities
- Provide regulatory inspection and document support for health authorities
- Review and approve analytical data test reports and certificates of analysis
- Write review and approve quality control documents
Perks/Benefits
Skills/Tech-stack
Analytical method validation | Analytical testing | CAPA | CGMP | Calibration | Data Management | Deviation Management | Document Control | GDP | Instrumentation Qualification | Method transfer | Method validation | OOS Investigation | OOT Investigation | Pharmaceutical manufacturing | Quality Control | Regulatory Compliance
Education
Regions
Countries
States
Cities
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