What are the responsibilities and job description for the Product Quality Complaint Specialist position at GForce Life Sciences?
Product Quality Complaint Specialist
12-month Contract
Hybrid - 2 days/week onsite in Princeton, NJ
Responsibilities:
• Manage the receiving and handling (documentation, coordination, investigation, resolution,
{replacement/reimbursement} 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 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
management if any discrepancy is found.
• Monitor complaints for product trends and notify management of events requiring immediate Action.
Requirements:
• 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 TrackWise