Staff Quality Assurance

Beckman Coulter Diagnostics; Hebron Estates (KY); On-site; USD 85,000 - 110,000; Full time

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Staff Quality Assurance professional for our Hebron, KY reagent manufacturing site. You will provide QA leadership to ensure product quality and regulatory compliance across a multisite organization, interfacing with cross-functional teams to uphold high standards.

The role emphasizes non-conformance management, process validations, and audit readiness, with travel up to 20%.

Qualifications

• Bachelor’s degree with 8+ years of work experience OR Master’s degree with 6+ years of work experience OR Doctoral degree with 3+ years of work experience.
• Articulate the risk impact of nonconformances on product quality.
• Ability to influence without direct authority and communicate complex/large impact product quality issues in a leadership setting.
• Familiarity with test method science and validation principles (IQ/OQ/PQ).

Responsibilities

• Manage process and product non-conformances and lead QA for product and process validations within the site.
• Provide QMS guidance and approvals for production deviations, nonconformances, and validation activities, including IQ/OQ/PQ.
• Support audit and inspection readiness activities and resolve findings.
• Monitor performance and collaborate with cross-functional teams and site leadership to address moderate-complex quality issues.

Skills

Quality assurance

Regulatory compliance

Leadership

Education

Bachelor’s degree

Master’s degree

Doctoral degree

Tools

IQ/OQ/PQ

Job description

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

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

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 Staff Quality Assurance provides quality assurance leadership to ensure the integrity of products manufactured, services provided to support business and customer needs, and comply with government regulations, industry and company standards. May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards. Will support and may lead audit and inspection preparation, resolution of audit and inspection findings. May be responsible for performance monitoring and will have frequent interaction with other functional areas and operating entities including site leadership. This position reports directly to the Senior Manager Quality Assurance and is an on-site position at the Hebron, KY Reagent Manufacturing site and a critical part of a large multisite US operations quality organization.

In This Role, You Will Have The Opportunity To

• Manager process and product non-conformances in line with company procedures and may review, investigate, resolve and report on quality discrepancies; support and act as quality assurance lead for product and process validations within the manufacturing site.
• Partner with manufacturing professionals to provide QMS guidance and approvals for production deviations, nonconformances, and validation activities, including test method validation and IQ/OQ/PQ.
• Support—and, when needed, lead—audit and inspection readiness activities, including the resolution of resulting findings.
• Monitor performance and collaborate frequently with cross-functional teams, other operating companies, and site leadership to navigate moderate-complex issues within the quality system.

The Essential Requirements Of The Job Include

• Bachelor’s degree with 8+ years of work experience OR Master’s degree with 6+ years of work experience OR Doctoral degree with 3+ years of work experience.
• Articulate the risk impact of nonconformances on product quality
• Ability to influence without direct authority and communicate complex / large impact product quality issues in a leadership setting
• Familiarity with test method science and validation principles (IQ/OQ/PQ)

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel – no more than 20%
• Ability to lift, move or carry equipment up to 25lb, any other physical requirements

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

• ASQ or accredited certifications in Quality and or engineering preferred.

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. For more information, visit www.danaher.com. 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. For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].