- Location: NJ, United States
- Type: Contract
- Job ID: 10176
- Work Setting: On-Site
- Posted: March 12, 2026
- Closing Date: March 12, 2027
- Tax Status: W2
Product Quality Complaint Investigator
12-month Contract
Hybrid in Princeton, NJ (2x onsite per week)
Responsibilities:
• Manage the receiving and handling (documentation, coordination, investigation, resolution, replacement/reimbursement} and closeout) of all Product Quality Complaints in a timely manner that complies with company requirements and Regulatory requirements (21CFR Parts 210, 211, 820).
• Manage Complaint Sample retrieval.
• Follow-up with Complainant (Patient, Sales Reps, Hospitals, Pharmacies and Physicians etc.) to obtain applicable information pertaining to reported events.
• Review completed complaint files to assure 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 the management if any discrepancy is found.
• Monitor complaints for product trends and notify management of events requiring immediate Action. Conduct trend investigation as applicable.
• Generate monthly and quarterly PQC metrics for all products and provide report to management and present in meetings.
• Generate Risk Management metrics for Drug/Device combination product and Medical Device product and provide report to management.
• Gather data to assist with any potential recall and/or reporting actions.
• Manage reconciliation processes in coordination with other teams (call center, Pharmacovigilance, and medical information etc.) to ensure it meets procedure requirement and timely completion.
• Support, manage and complete assigned projects in accordance with company requirements.
• Support Internal GMP audit and External Regulatory inspections.
• Complete all assigned training in a timely manner.
Qualifications:
• Bachelor’s Degree plus minimum 2 years of Quality Assurance experience in the pharmaceutical and/or 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 Track Wise
• Strong interpersonal and communication skills
• Strong writing skills
• Ability to work in a team environment.
• Ability to multi-task
Hybrid, 1 or 2x a week per business need. Days can be flexible.
12-month Contract
Hybrid in Princeton, NJ (2x onsite per week)
Responsibilities:
• Manage the receiving and handling (documentation, coordination, investigation, resolution, replacement/reimbursement} and closeout) of all Product Quality Complaints in a timely manner that complies with company requirements and Regulatory requirements (21CFR Parts 210, 211, 820).
• Manage Complaint Sample retrieval.
• Follow-up with Complainant (Patient, Sales Reps, Hospitals, Pharmacies and Physicians etc.) to obtain applicable information pertaining to reported events.
• Review completed complaint files to assure 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 the management if any discrepancy is found.
• Monitor complaints for product trends and notify management of events requiring immediate Action. Conduct trend investigation as applicable.
• Generate monthly and quarterly PQC metrics for all products and provide report to management and present in meetings.
• Generate Risk Management metrics for Drug/Device combination product and Medical Device product and provide report to management.
• Gather data to assist with any potential recall and/or reporting actions.
• Manage reconciliation processes in coordination with other teams (call center, Pharmacovigilance, and medical information etc.) to ensure it meets procedure requirement and timely completion.
• Support, manage and complete assigned projects in accordance with company requirements.
• Support Internal GMP audit and External Regulatory inspections.
• Complete all assigned training in a timely manner.
Qualifications:
• Bachelor’s Degree plus minimum 2 years of Quality Assurance experience in the pharmaceutical and/or 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 Track Wise
• Strong interpersonal and communication skills
• Strong writing skills
• Ability to work in a team environment.
• Ability to multi-task
Hybrid, 1 or 2x a week per business need. Days can be flexible.