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Remote Complaint Investigator - Product Quality IV

Princeton, NJ 08540

Posted: 05/31/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 567819 Is job remote?: Yes Country: United States

Job Description

Pay rate 50-58.80 depending on experience

\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
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