Product Quality Complaint Investigator

Product Quality Complaint Investigator12-month Contract Hybrid - Princeton, NJResponsibilities: • Manage the receiving and handling (documentation, coordination, investigation, resolution, {replacementreimbursement} and closeout) of all Product Quality Complaints in timely manner that complies with company requirements and Regulatory requirements (21CFR Parts 210, 211, 820).• Manage Complaint Sample retrieval.• Follow-up with the Complainant (Patient, Sales Reps, Hospitals, Pharmacies, Physicians etc.) to obtain applicable information pertaining to reported events.• Review completed complaint files to ensure proper documentation, coordination, investigation, resolution, and closeout and ensure compliance to regulatory requirements as well as company requirements.• Review contact center calls to ensure proper triage and documentation. Provide feedback to management if any discrepancy is found.• Monitor complaints for product trends and notify management of events requiring immediate Action. As applicable conduct trend investigation.• Generate monthly and quarterly PQC metrics for all products and provide report to management and present in meetings.• Generate Risk Management metrics for DrugDevice combination product and Medical Device product and provide report to management.Qualifications: • Bachelor's Degree plus minimum 2 years of Quality Assurance experience in the pharmaceutical andor medical device industry• Strong knowledge of regulatory requirements (21 CFR Parts 210, 211, 820) specifically those applicable to complaint handling, investigations, and documentation• Excellent analytical, problem solving, and troubleshooting skills.• Proficient in MS Office software and TrackWise• Strong interpersonal and communication skills• Strong writing skills• Ability to work in a team environment.• Ability to multi-task

Created: 2025-02-22