Senior Calibration Specialist

Overview

The primary function of the Senior 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

Physical Requirements :