About The Position

At Beckman Coulter Diagnostics, an operating company of Danaher, the work focuses on accelerating potential and making a difference in life sciences, diagnostics, and biotechnology. The company is a global leader in clinical diagnostics, with over 90 years of experience, providing diagnostic solutions used in routine and complex clinical testing in hospitals, reference and research laboratories, and physician offices worldwide. Over one million tests are run on Beckman Coulter Diagnostics systems every hour, impacting 1.2 billion patients and over three million clinicians annually. The company aims to enable clinicians to deliver the best possible care through improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. The Analyst I Quality Assurance, Calibration Coordinator is responsible for scheduling and ensuring the timely calibration of inspection, measuring, and test equipment used at the Beckman Coulter Chaska manufacturing facility. This is an on-site role located in Chaska, MN, and reports to the Quality Assurance Manager as part of the Quality Assurance team.

Requirements

  • Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences or other relevant baccalaureate degree and 2+ years of relevant experience
  • Experience in a laboratory setting utilizing Good Manufacturing and Good Laboratory Practices including the use and calibration of inspection, measuring and test equipment.
  • Experience with 21 CFR 820.72, ISO 9001 and 17025, and ANSI/NCSL Z540 in a biotech setting

Nice To Haves

  • Scheduling equipment for calibration and/or maintenance activities using a calibration management software program
  • Metrology Testing Lab
  • ASQ Certification – CCT

Responsibilities

  • Work with Area Calibration Representatives in a leadership capacity to ensure local inspection, measuring and test equipment is tracked and calibrated in a timely manner.
  • Work with site OOT manager, OOT investigators and calibration service personnel to ensure all out of tolerances conditions are identified, investigated for process / product impact and a report thereof prepared / completed.
  • Create and revise area calibration procedures
  • Prepare and communicate calibration status metrics, including OOT tracking.
  • Train area calibration representatives regarding area procedures for general calibration activities and OOT procedure.
  • Interface with Global Process Owner for calibration and attend and participate in periodic global calibration team meetings.

Benefits

  • broad array of comprehensive, competitive benefit programs that add value to our lives.
  • health care program
  • paid time off
  • medical/dental/vision insurance
  • 401(k)
  • bonus/incentive pay
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