Analyst I Quality Assurance, Calibration Coordinator

Beckman Coulter Diagnostics; Chaska (MN); On-site; USD 42,705 - 46,838; Full time

Benefits offered by this job

Bonus incentive pay

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

Beckman Coulter Diagnostics in Chaska, MN is seeking an Analyst I Quality Assurance, Calibration Coordinator to lead calibration activities for inspection, measuring and test equipment at the Chaska facility. This on‑site role reports to the Quality Assurance Manager and is part of the Quality Assurance team located in Chaska, MN.

The role requires a Bachelor’s degree in engineering or life sciences and 2+ years of relevant experience, with knowledge of GMP/GDP and calibration standards.

Qualifications

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

Responsibilities

• Lead Area Calibration Representatives to ensure local inspection, measuring and test equipment is tracked and calibrated in a timely manner.
• Collaborate with site OOT manager, OOT investigators and calibration service personnel to identify and investigate all out‑of‑tolerance conditions, assess process or product impact, and prepare reports.
• Create and revise area calibration procedures; prepare and communicate calibration status metrics, including OOT tracking.
• Train area calibration representatives on general calibration activities and OOT procedures.
• Interface with Global Process Owner for calibration and participate in periodic global calibration team meetings.

Education

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences or related field

2+ years of relevant experience

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Beckman Coulter Diagnostics is one of Danaher’s operating companies. Our work saves lives and is driven by a commitment to innovate for tangible impact. Over 90 years we have challenged convention to elevate the diagnostic laboratory’s role in improving patient health worldwide. More than one million tests are run on our systems every hour, benefiting 1.2 billion patients and more than three million clinicians annually.

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 on‑site role reports to the Quality Assurance Manager and is part of the Quality Assurance team located in Chaska, MN.

In This Role

• Lead Area Calibration Representatives to ensure local inspection, measuring and test equipment is tracked and calibrated in a timely manner.
• Collaborate with site OOT manager, OOT investigators and calibration service personnel to identify and investigate all out‑of‑tolerance conditions, assess process or product impact, and prepare reports.
• Create and revise area calibration procedures; prepare and communicate calibration status metrics, including OOT tracking.
• Train area calibration representatives on general calibration activities and OOT procedures.
• Interface with Global Process Owner for calibration and participate in periodic global calibration team meetings.

Essential Requirements

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

Preferred Experience

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

Benefits

The hourly range for this role is $31–$34. This is a forum for compensation at the time of posting and may be modified in the future. The role is also eligible for bonus/incentive pay. Employees have access to paid time off, medical/dental/vision insurance, a 401(k) plan and a broad array of other comprehensive benefits.

Equal Employment Opportunity

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here.