Remote Complaint Investigator - Product Quality IV
Remote Princeton, NJ 08540 US
\Clinical Product Quality Complaints and Systems role:
• Manages the receiving and handling (documentation, coordination, investigation, resolution, and closeout) of OPDC Clinical Product Quality Complaints for drug products/medical devices/combination products in a manner that complies with regulatory requirements (21CFR Parts 210, 211, 820).
• Writes and/or reviews clinical product quality complaint investigations, vendor quality events, deviations, change controls and CAPAs and ensure they are appropriately documented in TrackWise.
• Reviews vendor investigations and completes TrackWise.
• Oversee complaint records ensuring proper documentation, coordination, investigation, resolution, and closeout and ensures compliance with regulatory requirements as well as business requirements.
• Follows up with call center, clinical sites, vendors, and internal company functional areas to obtain applicable information pertaining to reported events.
• Leads protocol specific PQC call center training and PQC training of the clinical site
• Ensures clinical PQCs are reconciled in a timely manner with Global Pharmacovigilance Team.
• Monitors complaints for product trends and notifies Manager of events requiring immediate action.
• Participates in internal audits and supports inspection readiness activities
• Authors and maintains Standard Operating Procedures, Work Practices, Job Aids, and other related documents.
• Co-ordinates periodic review of SOPs, WPs and Job Aids within the department and ensures all comments are consolidated and provided to KS by established timelines.
• Generates Monthly and Quarterly Metrics for periodic Quality Management reviews and presentations.
• Provides periodic updates via SMT Presentation
• Assists with Quality System initiatives/improvements as R&D e-systems representative for the GPQ group. Systems to include but are not limited to TrackWise, GQEDMS.
• Completes Quality System UAM and UAT testing for system improvement/transition activities
• Maintains GMP records (document storage, archiving, retrieval).
• Bachelor’s degree in Engineering, Chemistry, Biology or related Science
• 5 years of related experience in Pharmaceutical/medical device industry in Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Product or Commercial Product
• Trackwise is a must
• Complaints processing experience is preferred
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.