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Calibration Technician
Ref No.: 20-00502
Category: Biotechnology
Location: Congers, New York
This position oversees, coordinates, and executes equipment and facility calibrations activities in accordance with ISO 15378, 14001 and cGMP.

Responsibilities
  • Ensure the calibration status of process, inspection, measuring and test equipment at the site.
  • Tracks calibrations/Preventative Maintenance through assigned management software.
  • Accountable for communication and coordination with stakeholders regarding schedule and impact of calibration activities being performed.
  • Coordinate calibration activities with department managers, maintenance personnel, production leads, and external vendors.
  • Investigate root cause of instrument malfunction and non-conformity with SME and assess impact and risk.
  • Consult suppliers of measuring instruments and calibration laboratory to help resolve issues with calibrated instruments.
  • Audit calibration providers, negotiate deadlines, submit quotes and establish purchase requests.
  • Create, revise, edit and validate calibration SOP's in accordance with current standards
  • May be asked to develop validation protocols for select laboratory equipment.
  • Initiate/complete various types of GMP documentation such as change control, deviations, corrective and preventive actions (CAPAs), documentation revision.

Qualifications
  • High school or technical school education. Bachelor's Degree in a technical field preferred.
  • 2 to 5 years' experience in a high-volume manufacturing industry.
  • 1-3 years of experience in Calibration

Skills/Abilities
  • Good analytical skills.
  • Self-Starter with good technical writing and communication skills.
  • Detail oriented and rigorous.
  • Disciplined and able to work with a diverse team with minimal supervision.
  • Good knowledge of Microsoft Excel, Word, and PowerPoint.
  • Experience in a cGMP environment - FDA regulated or ISO 15378 is preferred.