Calibration Coordinator

The Calibration Coordinator is responsible for administering and maintaining the calibration program that ensures compliance with U.S. FDA regulations (21 CFR Parts 210/211 and 21 CFR Part 820) as well as international regulatory requirements and industry standards. This role supports product quality, data integrity, and inspection readiness across multiple regulatory jurisdictions, ensuring all instruments and systems are calibrated, documented, and controlled in accordance with global GMP and quality system expectations.

• Coordinate and manage the calibration program for manufacturing, laboratory, and facility equipment.
• Maintain calibration schedules aligned with regulatory requirements and risk-based methodologies.
• Track and report key performance indicators (KPIs) (e.g., completion rates, overdue calibrations, OOT trends).

The Calibration Coordinator is responsible for administering and maintaining the calibration program that ensures compliance with U.S. FDA regulations (21 CFR Parts 210/211 and 21 CFR Part 820) as well as international regulatory requirements and industry standards. This role supports product quality, data integrity, and inspection readiness across multiple regulatory jurisdictions, ensuring all instruments and systems are calibrated, documented, and controlled in accordance with global GMP and quality system expectations.

• Coordinate and manage the calibration program for manufacturing, laboratory, and facility equipment.
• Maintain calibration schedules aligned with regulatory requirements and risk-based methodologies.
• Track and report key performance indicators (KPIs) (e.g., completion rates, overdue calibrations, OOT trends).

Ensure compliance with applicable regulations and standards, including but not limited to:

• U.S. FDA
  • 21 CFR Part 210/211 (cGMP – Pharmaceuticals)
  • 21 CFR Part 820 (Quality System Regulation – Medical Devices)
• European Union
  • EU GMP (Eudra Lex Volume
    4)
  • Medical Device Regulation (EU MDR 2017/745) and IVDR (as applicable)
• International Standards
  • ISO 13485 – Medical Device Quality Management Systems
  • ISO 9001 – Quality Management Systems
  • ISO/IEC 17025 – Calibration and Testing Laboratory Competence
• ICH Guidelines
  • ICH Q7, Q8, Q9, Q10 (Quality Risk Management, Pharmaceutical Quality Systems)
• Other Regulatory Bodies (as applicable)
  • MHRA (UK), Health Canada, TGA (Australia), PMDA (Japan), etc.
• Ensure alignment with data integrity guidance (FDA, MHRA, PIC/S).
• Maintain continuous inspection readiness for global regulatory inspections and customer audits.

• Maintain calibration records, certificates, and traceability per ALCOA+ principles.
• Ensure calibration standards are traceable to NIST, SI units, or equivalent international standards.
• Manage calibration data within CMMS and/or validated systems in compliance with:
  • 21 CFR Part 11 (Electronic Records/Electronic Signatures)
  • Annex 11 (EU computerized systems)
• Review calibration documentation for technical accuracy and regulatory compliance.

• Lead or support investigations for calibration failures and out-of-tolerance conditions.
• Conduct product impact assessments using risk-based methodologies (ICH Q9).
• Collaborate on CAPA activities to ensure effective root cause resolution and compliance.
• Support deviation, change control, and nonconformance processes.

• Coordinate external calibration service providers and laboratories.
• Ensure vendors are qualified per:
  • ISO/IEC 17025 accreditation
  • Internal supplier quality requirements
• Review vendor documentation and audit performance where required.