QA Specialist - Deviations
American Regent(2 months ago)
About this role
The QA Specialist – Deviations ensures non‑routine manufacturing and laboratory events are investigated, documented, and approved according to SOPs, cGMPs and regulatory requirements. The role works cross‑functionally across all departments to manage deviations, perform root‑cause analysis, and support audits and CAPA processes.
Required Skills
- Investigation
- CAPA
- Root Cause
- Documentation
- Auditing
- Metrics
- Communication
- Collaboration
- Statistical Analysis
- Quality Systems
+1 more
Qualifications
- Bachelor's in Science or Engineering
- ASQ Certified Quality Engineer
- Six Sigma Black Belt
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