CALIBRATION COMPLIANCE SPECIALIST III in Boston, Massachusetts at MENTOR TECHNICAL GROUP CORP

Position Summary:

The Calibration Compliance Specialist supports the Metrology department in a regulated life sciences environment. This role performs and supports metrology activities, verifies that calibration records and reference standards are managed in accordance with applicable requirements, and works with Quality and Metrology teams to investigate issues and implement corrective actions.

• Perform and support metrology activities in accordance with applicable U.S. Food and Drug Administration (FDA) and European Union (EU) regulatory requirements, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), industry standards, and site procedures.

• Review calibration records for accuracy, completeness, traceability, and compliance with approved procedures.

• Verify that reference standards are within their calibration intervals and that their use, status, and traceability are documented.

• Identify documentation or process gaps and work with the appropriate teams to resolve them.

• Lead or support the preparation and implementation of change controls affecting calibration procedures, equipment, reference standards, or metrology processes.

• Draft and review incident reports, deviation reports, and other quality records. Document event details, impact assessments, and supporting evidence in accordance with site procedures.

• Coordinate with Quality, Metrology, and other affected teams to track assigned actions through completion and support timely closure of quality records.

• Lead or support investigations of metrology-related quality events, including out-of-tolerance calibration results, missed calibrations, and documentation discrepancies.

• Perform root cause analysis using calibration records, equipment history, and other relevant evidence.

• Identify and document corrective and preventive actions (CAPAs) that address investigation findings. Support implementation and effectiveness checks as assigned.

• Bachelor’s degree in engineering, science, or a related technical field, or equivalent relevant experience.

• Experience in metrology, calibration, or quality compliance within a GMP-regulated manufacturing environment.

• Working knowledge of calibration documentation, measurement traceability, and reference standard management.

• Experience with deviation investigations, change control, root cause analysis, and CAPA processes.

• Strong technical writing skills and the ability to coordinate across Metrology, Quality, Engineering, and Operations.