Job Description

This position is responsible for overseeing the calibration of laboratory and production equipment in a GMP facility, ensuring compliance with regulatory standards. Support the management of metrology technicians, develop and implement calibration procedures, and maintain documentation related to equipment qualification and validation.  

cGMP Consulting is looking for an individual who is efficient, comfortable working independently, and who will handle multiple projects and priorities, work with tight deadlines, address high priority requests, and effectively lead and manage multiple projects to completion. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment.

Responsibilities

• Manage activities pertaining to calibrations, routine inspections, testing and repairs of instruments and equipment.
• Ensure timely completion of scheduled and demand calibration work orders.
• Improve calibration performance through: calibration system enhancements, control of calibration due date delinquencies, control of bad actors, Cal-Alert cycle time, control of status reported instruments and act as a liaison to Corporate Metrology.
• Perform and remediate all nonconformance issues such as, status reports, bad actors and calibration delinquencies.
• Provide equipment owner support: Advise instrument owners/departments on calibration related issues.
• Assist in the selection of the appropriate instruments for intended use.
• Assure that adequate programs exist at the user level to ensure users are properly trained in the use and car of calibrated instruments.
• Work with client representatives to fully understand needs and solve problems and they arise.
• Ensure safety standards at the client ate met and adhere to safe working practices.
• Communicate resource needs to the cGMP Consulting team to ensure continued project success and completion.
• Schedule, lead, and participate in meetings and discussions related to assigned client projects.

Position skills and requirements:

• Minimum 5+ year experience in metrology.
• Applied knowledge of calibration program requirements.
• Knowledge of cGMP, USP and ICH regulations and standards as they pertain to calibration and metrology.
• Experienced with laboratory and production equipment.
• Understanding of equipment validation requirements and process.
• Strong organization and computer skills.
• Highly motivated and independent individual.
• Detail oriented and comfortable working in a fast-paced office environment.
• Exceptional communication and leadership skills.
• Superior organizational, communication, and interpersonal skills are necessary.