Calibration Coordinator

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.

Essential duties and responsibilities include:

• Program management
• Regulatory compliance and global standards
• Documentation and data integrity
• Out-of-tolerance investigations and quality systems
• Vendor and laboratory management
• Cross-functional collaboration
• Continuous improvement and global harmonization

Expectations include:

• 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 include:

• 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 include:

• 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 include:

• 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