Sr Specialist QA
Posted
Summary
Senior QA specialist at a pharmaceutical manufacturing site in Juncos, Puerto Rico, performing facilities/utilities commissioning, computer system and equipment validation, risk assessments, change controls, and documentation work using tools like KNEAT, TrackWise, SCADA, and Maximo. Bilingual Spanish/English required.
Sr Specialist QA with experience in:
- 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 in Decision Making Techniques
- Risk Management
Requirements
- 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 - Bilingual (Spanish/Engilsh)
- Strong knowledge in Decision Making Techniques