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.