Sr Specialist QA
Posted
Summary
Senior QA specialist for a pharmaceutical manufacturing operation in Juncos, Puerto Rico: reviews and approves product master files, validation protocols and environmental reports, represents QA on triage/NPI teams, and leads investigations. Requires pharma QA experience with commissioning/qualification, computer system validation, and tools like KNEAT, TrackWise, SCADA and Maximo.
We are seeking a Sr. Specialist QA to support Quality Assurance program acts as the technical specialist. Review and approve product MPs.
FUNCTIONS
- 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.
Requirements
Education: Doctorate + 2 years of directly related experience or Masters + 4 years of directly related experience or Bachelors + 6 years of directly related experience or Associates + 10 years of directly related experience or High school/GED + 12 years of directly related experience.
Experience with:
- 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