Risk Assessment & Technical Documentation Analyst (FT, Contract)

Full-Time Contract Risk Assessment & Technical Documentation AnalystOur 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- , CAPA- , and ICP- . 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 specializationManaging Excel filesPerforming RPN calculationsData organization and traceabilityManaging deliverables to keep the program movingDay-to-Day Responsibilities:Managing documentation development and data organization for intervention assessmentsPerforming risk modeling and Risk Priority Number (RPN) calculations in ExcelMaintaining CAPA traceability across metricsManaging deliverables to ensure the program meets its year-end goalsThe 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.