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Senior Calibration Specialist
Bloomington, United States
Overview:
Physical Requirements:
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
- Associates Degree in a technical discipline specific to calibration and instrumentation, or experience of such kind and amount as to provide a comparable background
- 5 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.
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