Full-Time Contract Risk Assessment & Technical Documentation Analyst Our client is hiring a Full-Time Contract Risk Assessment & Technical Documentation Analyst for a full-time contract project through the end of the year to address FDA 483 audit findings and support CAPA-102537, CAPA-102539, and ICP-100445. In this role, the analyst will manage documentation development, risk modeling, data management, Excel spreadsheets, RPN calculations, and CAPA traceability for 100+ high-risk manual interventions in legacy aseptic fill-finish processes.
Experience:- Documentation and risk management specialization
- Managing Excel files
- Performing RPN calculations
- Data organization and traceability
- Managing deliverables to keep the program moving
Day-to-Day Responsibilities:- Managing documentation development and data organization for intervention assessments
- Performing risk modeling and Risk Priority Number (RPN) calculations in Excel
- Maintaining CAPA traceability across metrics
- Managing deliverables to ensure the program meets its year-end goals
The company provides sterile injectables and offers clinical and commercial non-viral aseptic fill/finish services for vials and pre-filled syringes on four fill lines, in addition to lyophilization, terminal sterilization, analytical, stability, packaging and serialization, and additional support services.
