Calibration Specialist

Cook Group; Bloomington (IN); On-site; USD 52,000 - 76,000; Full time

Job summary

Cook Group is seeking a Calibration Specialist I to perform and support calibration and repair of Inspection, Measurement and Test Equipment (IM&TE) within a cGMP framework. You will execute calibration activities using traceable reference standards and maintain compliance with FDA and ISO requirements.

The role requires an associates degree in a technical calibration field or equivalent experience, 2 years of calibration experience, and familiarity with CCMS and Microsoft Office tools.

Qualifications

• Associates Degree in a technical discipline specific to calibration and instrumentation.

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.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
• Ability to remain calm and receptive in fast paced situations.

Skills

Effective communication

Education

Associate's Degree in a technical discipline related to calibration and instrumentation

Tools

CCMS

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Overview

The primary function of the Calibration Specialist I 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.


• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.


• Must strictly adhere to safety requirements.


• Maintain regular and punctual attendance.


• Must maintain company quality and quantity standards.


• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.


• Ability to remain calm and receptive in fast paced situations.

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.


• 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.