Quality Compliance Associate II

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
 
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

This position, Quality Compliance Associate II, is part of the Quality Assurance Team located in Fargo, ND and will be onsite. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Quality Compliance Team and report to the Manager of Quality Compliance responsible for management of the Quality Systems implemented by Aldevron. 

In this role, you will have the opportunity to:

• Review Quality System records inclusive of complex Deviations, CAPAs, and Change Controls. This would be the quality review responsible for approval as quality entity ensuring compliance of the record to governing regulations. 
• Assess events through cross-functional collaboration to ascertain product impact. Lead Quality System Review Board meetings and serve as Quality department stakeholder.
• Support quality project that will Enhance site wide compliance by working with Operational and other Quality stakeholders. 
• Author Quality System records as needed and participate in client discussions pertaining to Quality System inquiries. 
• Support cross-training in other functional areas of QA as requested by management. 

The essential requirements of the job include: 

• Bachelor of Science in Biology, Microbiology, Chemistry, or other life science field preferred. Bachelor of Arts acceptable
• 2+ years of experience in Quality Assurance within a regulated industry. Experience in other facets of pharmaceuticals may be substituted. 
• Previous experience with Quality System records.  

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

• Biologics or drug experience a bonus
• Certification from ASQ or RAPS a plus

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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.

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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation.