Senior Specialist, Quality Systems

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 is part of the Quality Assurance Team located in Fargo, ND. 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 Assurance team and report to the Director, QA Compliance, responsible for maintaining various aspects of the Quality System, including deviation, CAPA, change control, document control and risk management.

In this role, you will have the opportunity to:

• Collaborate with cross-functional teams (internal and external) to establish and maintain document controls that align with applicable regulatory requirements. Ensure compliance with documentation requirements defined in 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q9, ICH Q10, and other international guidelines as appropriate. Ensure compliance throughout the document/record lifecycle: including the creation, approval, issuance, revision, retention, timely retrieval during audits, and obsoletion.
• Review and approve deviations, CAPAs and change controls within the Quality System. Participate in various Quality System review boards to determine the need for quality records, categorization and client impact.
• Lead in the development, implementation and oversight of risk management principles at the site. Monitor and report major and critical risk issues to ensure mitigating actions are implemented in a timely manner.
• Collaborate with cross-functional teams to ensure effective risk controls are in place.
• Serve as the Quality System Subject Matter Expert in client visits and audits.

The essential requirements of the job include:

• 5+ years of industry experience in Quality Systems; biotech, pharma, drug product, or medical device document control experience preferred
• Experience with risk tools (qualitative/quantitative) and knowledge of ICHQ9 desired.
• Excellent analytical, problem solving, and decision-making skills.
• Bachelor’s Degree required; life science related field, preferred.
• Strong foundational knowledge in current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP).

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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.