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Lead Calibration Specialist

$90,000    Burlington, MA
•  Direct Hire
•  Job Number:256194
•  Posted:9/15/2024

95000.00

Direct hire

Lead the Manufacturing Calibration process in the regulated (by FDA) industry environment. Sustain the Quality team in electronic documentation process transition.

Primary responsibility:

Support the manufacturing team in daily production activities.

Function as main point of contact with external calibration vendors to resolve all issues and coordinate efforts.

Conduct routine testing of equipment per work instruction documentation.

Perform maintenance of equipment per work instruction documentation.

Prepare reports including Work Orders (WO), IQs, and more.\Review external vendor certifications for completeness and accuracy.

Support with OOT investigations and reviews. Applies theoretical principles, evaluation, ingenuity, and creative/analytical techniques to identify route cause of calibration problem.

Train calibration procedures as required to enhance personal skillset.

 

Requirements

EDUCATION AND EXPERIENCE

  • Technical Degree or Certificate
  • ASQ Certified Calibration Technician (CCT) is preferable.
  • 7+years of working experience as a Calibration Specialist in Regulated Industries.
  • Requires demonstrated knowledge/understanding of GMP, other key practices and procedures of the function, company products, polices, and programs.
  • Proficient in using various PC-based document control software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software.
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