Senior QA Complaint Investigator

Job Summary

Senior QA Complaint Investigator is a remote contract position responsible for managing and documenting product complaints, conducting investigations, and ensuring compliance with Good Documentation Practices.

Key Responsibilities

• Triage incoming complaints and engage with call center as necessary
• Initiate customer complaints and manage investigations from start to completion
• Monitor complaint investigation CAPAs for effectiveness and adherence to commitments

Required Qualifications

• 5+ years of Quality/Product Investigation experience in the biotech or pharmaceutical industry
• Demonstrated skill in facilitating complex investigations from initiation to completion
• Knowledge of Root Cause Analysis (RCA) process
• Experience with processes involved in manufacturing and distribution, QA, QC, validation, and process development
• Experience working on Supplier Corrective Action Reports (SCAR) preferred