CALIBRATION COMPLIANCE SPECIALIST III

ADP, Inc.; Boston (MA); On-site; USD 100,000 - 118,000; Full time

Job summary

MTG CALIBRATIONS Boston is seeking a Calibrations Compliance Specialist III to support metrology activities in a regulated life sciences environment. You will verify calibration records, maintain traceability, and collaborate with Quality and Metrology teams to implement corrective actions.

Responsibilities include leading change controls, drafting incident and deviation reports, and coordinating actions to closure while ensuring compliance with FDA/EU requirements and GDP standards.

Qualifications

• Metrology, calibration, or quality compliance in GMP-regulated manufacturing.
• Knowledge of calibration documentation and traceability management.
• Experience with deviation investigations, change control, RCA, and CAPA processes.
• Strong technical writing and cross-functional coordination.

Responsibilities

• Perform metrology activities per FDA/EU GMP, GDP, and site procedures.
• Review calibration records for accuracy, completeness, and traceability.
• Lead or support change controls affecting calibration procedures and standards.
• Lead or support investigations of quality events and document CAPAs.

Skills

Metrology experience

Quality compliance

Documentation & traceability

Cross-functional coordination

Education

Bachelor's degree in engineering/science or related field

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

CALIBRATION COMPLIANCE SPECIALIST III

MTG CALIBRATIONS Boston, MA, US

2 days ago Requisition ID: 1129

Salary Range: $100,000.00 To $118,000.00 Annually

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.

Key Responsibilities:

Compliance and Regulatory Support

• 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.

Quality Events, Deviations, and Change Control

• 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.

Root Cause Analysis and CAPA Support

• 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.

Qualifications

• 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.