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 and will Remote. 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 Developing and implementing personnel training processes and procedures.
In this role, you will have the opportunity to:

• Collaborate with cross-functional teams (internal and external) to establish and maintain training strategies that align with applicable regulatory requirements. Ensure compliance with training requirements defined in 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q8, ICH Q9, ICH Q10, and other international guidelines as appropriate.
• Ensure personnel training requirements have been established and are maintained to address onboarding, role specific training, and changes in roles. Facilitating Quality based trainings for entire enterprise.
• Lead cross-functional assessment of new and revised procedures to ascertain appropriate training levels (read and understand, exam, qualification, etc.).
• Ensure training reports are available and disseminated throughout the organization, and ensure the training records are retained and assist/support the team during audits through the timely retrieval of these quality records.
• Create training related metrics and disseminate to site leadership.

The essential requirements of the job include:

• 5 years of relevant experience in creating/facilitating training programs; biotech, pharma, or medical device document control experience preferred
• Experience with establishing and maintaining training programs in electronic document management systems, MasterControl experience preferred.
• Bachelor’s Degree required; life science related field, preferred.
• Strong foundational knowledge in competency based/application based training.
• 25% travel to Fargo, ND required.
• Experience with client auditing and regulatory inspections is preferred.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. 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 applyassistance@danaher.com to request accommodation.