Quality Auditor

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Aldevron one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

At Aldevron we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team youll help bring life-changing innovations to lifeimpacting millions around the world. We bring together deep scientific expertise an unwavering commitment to quality and a collaborative spirit to drive progress. Whether youre launching your career or bringing years of experience we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potentialone discovery at a time.

Learn about the Danaher Business System which makes everything possible.

The Quality Auditor is responsible for ensuring the integrity and effectiveness of Aldevrons Quality Management System by planning and executing internal and external audits that drive continuous compliance and operational excellence. This role safeguards product quality and regulatory readiness by identifying process gaps validating adherence to cGMP and global regulatory standards and partnering with crossfunctional teams to implement sustainable corrective actions.

This position reports to the Manager Quality Audits and is part of the Quality Systems team located in Fargo ND and will be an on-site role.

In this role you will have the opportunity to:

• Plan coordinate and conduct internal and external QMS and product-focused audits ensuring compliance and effectiveness by following internal SOPs and relevant auditing standards.
• Develop comprehensive audit checklists prepare and review audit reports and follow up on findings coordinating with technical specialists to ensure complete records and effective resolution.
• Maintain supplier qualifications oversee supplier notificationsoptimizestandard procedures for cGMP components and materials andmonitordomestic and international regulations to ensure compliance and update relevant personnel accordingly.

The essential requirements of the job include:

• Bachelors Degreerequired; ASQ Certified Quality Auditor preferred.
• Experience in a cGMP environment and in a quality role with a preference for experience in Compliance Supplier Management and Regulatory Affairs.
• Strong knowledge of quality systems including required expertise in ICH Q10 and 21 CFR Part 210/211; additional experience with cGMP ISO 13485 FDA and EU regulatory standards is preferred.
• Experience working with and effectively communicating with the FDA and other regulatory agencies.

Travel Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel occasional domestic travel for audits etc.

Aldevron a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

At Aldevron we believe in designing a better more sustainable workforce. We recognize the benefits of flexible remote working arrangements for eligible roles and are committed to providing enriching careers no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Aldevron can provide.

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 Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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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.

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- or .