Calibration Specialist

Cook Inc - Bloomington in; Bloomington (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

Cook Inc - Bloomington in Bloomington, IN is seeking a Calibration Specialist I to perform calibration and repair of inspection, measurement and test equipment, ensuring compliance with cGMP and ISO requirements. You will support calibration activities across electrical, temperature, dimensional and other parameters, working with multiple internal teams.

The role requires an associates degree in calibration or related discipline and about two years of calibration experience.

Qualifications

• Associates degree in a technical discipline or equivalent calibration background.
• 2 years calibration/instrumentation experience preferred.
• Familiarity with CCMS administration.
• Awareness of cGMP, CFR 820 and ISO regs.
• Proficient in Word, Excel, Outlook.
• Travel approx. 10%

Responsibilities

• Perform calibration of IM&TE and support calibration of equipment.
• Maintain calibration program tracking for cGMP equipment and systems.
• Follow methods based on measurement science and accuracy/precision requirements.
• Assist generation of QSPs, calibration instructions, deviation investigations, and change control docs.
• Coordinate with Facilities, Production Eng, R&D, Quality, and Admin teams.
• Correspond with approved service suppliers to ensure calibration of equipment and systems.

Skills

Calibration

Measurement

Documentation

cGMP

Quality compliance

Education

Assoc. degree in calibration

Tools

CCMS

Job description

Job Location(s) Bloomington IN United States

Job Locations US-IN-Bloomington

Position Type Full Time

Company Cook Inc - Bloomington

Category Facilities/Maintenance

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.

"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.