QA Investigator

Job Title QA Investigator (API Manufacturing / Sterile Fill Finish) Location Rensselaer, NY Client is hiring two separate resources: One with hands‑on API Manufacturing experience One with hands‑on Sterile Fill Finish Manufacturing experience Role Summary Seeking experienced QA Investigators to support deviation investigation backlog activities in GMP manufacturing environments. This is a hands‑on operational role requiring direct manufacturing floor investigation experience. Key Responsibilities Lead deviation investigations from initiation to closure Perform Root Cause Analysis (5 Why, Fishbone, 6M, Cause & Effect) Prepare investigation reports and documentation Support CAPA development, implementation, and effectiveness checks Assist with backlog remediation activities Collaborate with Manufacturing, QA, QC, and Technical teams Update SOPs and GMP documentation as needed Required Qualifications Experience in API Manufacturing OR Sterile Fill Finish Manufacturing Strong deviation investigation experience in GMP environments Shop floor manufacturing experience Root Cause Analysis and troubleshooting skills CAPA experience Strong technical writing and documentation skills Preferred Quality Operations experience QC Chemistry Lab experience Aseptic manufacturing experience Batch investigations and backlog remediation experience Interview Focus Candidates must demonstrate practical experience with: Real‑world deviation investigations RCA methodologies CAPA implementation and effectiveness evaluation Manufacturing/shop floor investigation examples #J-18808-Ljbffr Intellectt INC