Complaints Specialist, Quality
Merck
September 02, 2026
Remote friendly (West Point, PA)
United States
Operations
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.
Qualifications:
- 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.
Required Skills (examples): cGMP compliance, CAPA management, customer complaint management/resolution, data analysis, documentation/records review, FDA regulations, quality inspections/operations, process improvements.
Benefits (if applicable): medical/dental/vision, retirement (401k), paid holidays/vacation, and sick/compassionate days.
Application: Apply via https://jobs.merck.com/us/en (deadline as stated on the posting).
- 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.
Qualifications:
- 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.
Required Skills (examples): cGMP compliance, CAPA management, customer complaint management/resolution, data analysis, documentation/records review, FDA regulations, quality inspections/operations, process improvements.
Benefits (if applicable): medical/dental/vision, retirement (401k), paid holidays/vacation, and sick/compassionate days.
Application: Apply via https://jobs.merck.com/us/en (deadline as stated on the posting).