Analyst I Quality Assurance, Calibration Coordinator

Danaher CorporationChaska, MN
$31 - $34Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. The Analyst I Quality Assurance, Calibration Coordinator is responsible for scheduling and ensuring timely calibration of inspection, measuring and test equipment used at the Beckman Coulter Chaska manufacturing facility. This position reports to the Quality Assurance Manager and is part of the Quality Assurance team located in Chaska, MN and will be an on-site role. In this role, you will have the opportunity to: 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.

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

  • Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
  • Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.
  • Check out our benefits at Danaher Benefits Info.
  • We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
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