Job description

Location: Remote, candidate will need to be in the Princeton area to come onsite for meeting.
Product Quality Complaint Investigator

• Manages 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)
• Manages Complaint Sample retrieval
• Manages OPDC process pertaining to contact with healthcare professionals submitting product complaints
• Reviews completed complaint files to assure proper documentation, coordination, investigation, resolution and closeout and ensure compliance to regulatory requirements as well as business requirements
• Creates risk metrics on Maintena failure modes, complaint related CAPA trend analysis records and submit to management to ensure early detection of potential quality issues
• Gathers data to assist with any potential recall and/or reporting actions
• Monitors complaints for product trends and notify management of events requiring immediate action
• Follow-ups with Sales Reps, Hospitals, Pharmacies and Physicians to obtain applicable information pertaining to reported events
• Supports GPQ department continuous improvement activities and projects (e.g., Quality systems support, batch record review) in accordance with applicable regulations and business goals and objectives
• Leads multiple reconciliation processes in coordination with other teams to ensure quality control utilizing a Global Automated Reconciliation Tool

Job Type: Full-time

Pay: $42.00 per hour

Schedule:

• 8 hour shift

Work Location: Remote

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