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.