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Quality Control Technical Writer (Root Cause Investigation, CAPA)

myGwork - LGBTQ+ Business Community
Fargo, ND Full Time
POSTED ON 3/30/2025
AVAILABLE BEFORE 4/28/2025
This job is with Danaher, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly.

Quality Control Technical Writer

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 Control department 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 Control Clinical team, report to the QC Release Testing Manager, and be responsible for ownership of various technical writing and continuous improvement projects including deviation investigations, CAPAs, and change controls.

In This Role, You Will Have The Opportunity To

  • Lead and author deviation investigations including root cause analysis, trend investigation, and impact assessment
  • Manage Change Controls and CAPAs from initiation to closure
  • Perform document revisions including laboratory procedures and forms
  • Collaborate with cross-functional teams to drive problem solving and continuous improvement
  • Address client-facing requests through written and verbal communication

The Essential Requirements Of The Job Include

  • Bachelor's degree in a relevant scientific or technical field
  • Demonstrated skillset for root cause analysis and risk management tools (Fishbone Analysis, 5 whys, 6M, etc.) in a regulated laboratory environment
  • Prefer 2 years' experience with quality management systems and best practices.

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

  • Build and utilize cross-functional working relationships
  • Strong organizational and time management skills.
  • Excellent analytical skills with the ability to gather, interpret, and present data effectively.
  • Ability to work independently and manage multiple projects simultaneously.

This job is also eligible for bonus/incentive pay.

We offer a 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 Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

#thisisbelonging

#thebestteamisdiverse

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.

The EEO posters are available here.

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.

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