Analyst I Quality Assurance, Calibration Coordinator

Radiometer; Chaska (MN); On-site; USD 43,000 - 47,000; Full time

Benefits offered by this job

Paid time off

Medical insurance

401(k)

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, is seeking an Analyst I Quality Assurance, Calibration Coordinator at our Chaska, MN facility. You will schedule and ensure timely calibration of inspection, measuring and test equipment and work with calibration representatives.

The role reports to the Quality Assurance Manager and requires a Bachelor's in Engineering or Life Sciences, 2+ years in a lab with GMP/GLP practices, and familiarity with 21 CFR 820.72 and ISO/17025.

Qualifications

• In-depth knowledge of GMP/GLP and calibration practices.
• Bachelor’s degree in Engineering or Life Sciences required with 2+ years of experience.
• Experience with 21 CFR 820.72 and ISO 9001/17025 is preferred.

Responsibilities

• Schedule and ensure timely calibration of inspection, measuring and test equipment.
• Coordinate with area calibration representatives and site OOT investigators.
• Prepare calibration status metrics and communicate results.

Skills

Lab experience

GMP/GLP familiarity

Attention to detail

Communication skills

Education

Bachelor's degree in Engineering, Biomedical Engineering or Life Sciences

Tools

Calibration management software

Job description

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.

The essential requirements of the job include

• 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.

It would be a plus if you also possess previous experience in:

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

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.

The hourly range for this role is $31-34/hour. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.

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Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow.

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