Complaints Specialist, Quality

Responsibilities

• Lead customer complaint investigations, including second-person review, root-cause determination, event scope, product impact assessment, and CAPA identification.
• Where applicable, complete investigational test protocols to determine root cause and impact.
• Author notifications to applicable Health Authorities in response to complaints (as required).
• Support complaint work-in-progress in tier meetings/huddles; assign workload and manage complaint trackers.
• Facilitate Complaints Governance, Complaints Community of Practice (COP), and Health Authority Assessment meetings.
• Collaborate across IPT functional areas to drive robust processing and continuous improvement (including proactive process improvements and investigation CAPAs).
• Perform retention sample and batch record evaluations (as applicable).
• Draft/review/support Biological Product Deviation Reports (BPDR) and Adverse Event Quality Inspection Reports (AEQIRs).
• Support team/site safety, environmental, and compliance objectives.
• Use and champion Production System tools in problem-solving and daily complaint activities.

• Required
  
  Education:
  
  Bachelor’s degree in Life Sciences/Science/Engineering (preferred); or 4+ years direct GMP manufacturing/lab or regulatory experience in lieu of degree.
• Required Experience:
  
  1+ year post‑degree experience in GMP manufacturing/lab or pharmaceutical/biological quality, operations, technical, or regulatory support.
• Preferred:
  Customer complaint investigator/complaints support; deviation management investigator; biologics/vaccine/bulk sterile facility experience.

cGMP compliance, CAPA management, customer complaint management/resolution, data analysis, documentation/records review, FDA regulations, quality inspections/operations, process improvements.

• medical/dental/vision
• retirement (401k)
• paid holidays/vacation
• sick/compassionate days