Calibration Coordinator

SUMMARY

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Program Management

• 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).

Regulatory Compliance & Global Standards

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 (EudraLex 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.

Documentation & Data Integrity

• 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.

Out-of-Tolerance (OOT) Investigations & Quality Systems

• 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.

Vendor & Laboratory Management

• 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.

Cross-Functional Collaboration

• Partner with Engineering, Manufacturing, Quality, Validation, and Regulatory Affairs teams.
• Support equipment qualification (IQ/OQ/PQ) and lifecycle management.
• Provide calibration input into risk assessments, URS, and validation protocols.

Continuous Improvement & Global Harmonization

• Drive improvements in calibration processes using Lean, Six Sigma, or operational excellence tools.
• Implement digital solutions and system upgrades (e.g., CMMS, calibration management software).

EXPECTATIONS

• Perform duties following NACS, Inc. quality and safety standards
• Participate in team building, training, and department communications
• Understand and follow all attendance related policies
• Maintain a high level of personal and professional integrity
• Perform additional job responsibilities as assigned

QUALIFICATIONS

• High School Diploma or AA Degree at minimum with applicable work experience
• Bachelor’s degree in Engineering, Life Sciences, Metrology, or related technical discipline preferred
• 3-7+ years of calibration, metrology, or maintenance experience in a regulated pharmaceutical, biotech, or medical device environment
• Direct experience supporting global regulatory frameworks and audits
• Strong knowledge of cGMP and global GMP frameworks (FDA, EU, WHO)
• Strong knowledge of calibration principles and metrology best practices
• Strong knowledge of ISO/IEC 17025 laboratory requirements
• Familiarity with CMMS systems (e.g., Master Control, ETQ, SAP PM)
• Familiarity with data integrity principles and electronic systems compliance (Part 11, Annex 11)
• Familiarity with working knowledge of risk management tools and statistical analysis
• Strong organizational and coordination skills across multiple stakeholders
• High attention to detail and compliance mindset
• Ability to communicate effectively in a cross-functional environment
• Strong analytical and problem-solving capabilities
• Global regulatory expertise
• Inspection readiness and audit support
• Data integrity and compliance
• Risk-based decision making
• Cross-functional collaboration
• Continuous improvement mindset

WORKING CONDITIONS

• Office and GMP-regulated production/laboratory environments
• Ability to lift/carry/move up to 50 pounds.
• May require standing for extended periods of time.
• Expected to wear all required PPE.
• Safely work independently and around others by following all required procedures.

SUCCESS METRICS

• On-time calibration completion rate
• Reduction in overdue and OOT events
• Audit and inspection outcomes (FDA, EU, ISO)
• CAPA effectiveness and closure timelines
• Data integrity compliance metrics
• Vendor performance and compliance