Calibration Specialist

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 withminimal 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.