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Calibration Specialist

3 months ago

Bloomington, Indiana, United States Cook Group Full time

Overview:


The primary function of the Calibration Specialist at Cook Incorporated is to perform and support calibration and repair of Inspection, Measurement and Test Equipment, (IM&TE), while maintaining compliance to the Quality System.

This position is responsible for execution and continuous improvement of calibration and repair of IM&TE parameters such as electrical/electronic, temperature, physical, dimensional, humidity, frequency, torque, mass, and analytical measurements using traceable reference standards, following work order instructions, and adhering strictly to cGMP requirements.


Responsibilities:

  • Perform calibration of IM&TE, provide support to organization on new and existing equipment potentially needing calibration
  • Ensure maintenance of the calibration program tracking all equipment associated with cGMP equipment and systems
  • Follow and ensure compliance to methods and techniques based on principles of measurement science, technical analysis of measurement issues, accuracy and precision requirements
  • Assist with generation of QSPs, calibration instructions, deviation/failure investigations, change control documentation, and reports
  • Interface with various business functions including Facilities, Production Engineering, R&D, Quality, and Administration teams
  • Correspond with approved service suppliers to ensure appropriate calibration of equipment, instruments, and systems
  • Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
  • Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements

Qualifications:

  • Associates Degree in a technical discipline specific to calibration and instrumentation, or experience of such kind and amount as to provide a comparable background
  • 2 years of experience in calibration and instrumentation preferred
  • Awareness of Computerized Calibration Management Software (CCMS) administration and management
  • Awareness of cGMP, CFR 820 and ISO regulations
  • Knowledge of Microsoft Word, Excel, and Outlook

Physical Requirements:

  • Ability to travel approximately 10% as necessary to other facilities
  • Must be able to perform reasonable job functions requiring periods of sitting, standing, walking, communicating
  • Utilizes close visual acuity for working with computers, etc.