Consultant, Product Quality Complaint Investigator, Pharmaceuticals
Summary
Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Product Quality Complaint Investigator to support handling all aspects of product complaints. This candidate will report to the Product Compliant Manager and work cross-functionally with teams to ensure quality control.
General Duties / Expectations of Role:
- Manage the receiving and handling (documentation, coordination, investigation, resolution, and closeout) of all Product Quality Complaints and patient-related field events in a manner that complies with regulatory requirements (21CFR Parts 210, 211, 820)
- Manage Complaint Sample retrieval
- Manage process pertaining to contact with healthcare professionals submitting product complaints
- Review completed complaint files to assure proper documentation, coordination, investigation, resolution, and closeout and ensure compliance to regulatory requirements as well as business requirements
- Create risk metrics on failure modes, complaint related CAPA trend analysis records and submit to management to ensure early detection of potential quality issues
- Gather data to assist with any potential recall and/or reporting actions
- Monitor complaints for product trends and notify management of events requiring immediate action
- Follow-up with Sales Reps, Hospitals, Pharmacies, and Physicians to obtain applicable information pertaining to reported events
- Support GPQ department's continuous improvement activities and projects (e.g., Quality systems support, batch record review) in accordance with applicable regulations and business goals and objectives
- Lead multiple reconciliation processes in coordination with other teams to ensure quality control by utilizing a Global Automated Reconciliation Tool
Mandatory Requirements
- Bachelor’s degree
- 2+ years of working with product quality complaints
- Pharmaceutical/ Medical Device/ Biotechnology experience
- Strong knowledge of regulatory requirements (21 CFR Parts 210, 211, 820) specifically those applicable to complaint handling, investigations, and documentation
- TrackWise experience
Term & Start
- 12-month contract, open to 12+ month extension
- 1-2 Video Interviews - Start 2 weeks from an offer
- Full time, 40 hours/week
- Hybrid Opportunity – preference is the availability to work in Princeton NJ 2-3x a week
- Benefits included (Medical, Dental, Vision, 401k)
