Sr Specialist QA
QRC Group•Juncos, PR
About The Position
We are seeking a Sr. Specialist QA to support Quality Assurance program acts as the technical specialist. Review and approve product MPs.
Requirements
- Facilities and Utilities Commissioning and Qualification
- Computer System Validation
- Equipment validation
- Risk Assessments
- KNEAT,CDOCS, SCADA, TRACKWISE,MAXIMO
- Good Documentation Practices, Data Integrity
- Change Controls
- Standard Operation Procedure
- Syringe/Vials Inspection Process
- Documents revision and approval
- Strong knowledge of Decision Making Techniques
- Risk Management
Responsibilities
- Approve process validation protocols and reports for mfg. processes.
- Represent Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Own site quality program procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
