OQA Specialist II

2 months ago

Fargo, United States Aldevron Full time

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 Operational Quality Assurance department located in Fargo, ND and will be onsite working a second shift position. 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 Operational Quality Assurance Supervisor, responsible for providing quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards.

In this role, you will have the opportunity to:

  • Execute label generation to ensure identity and traceability of final material
  • Review GMP and GMP-S Batch Record Documentation
  • Complete review of Packaging generated secondary labels prior to packaging event
  • In-process release activities (i.e. suite review)
  • Review solution preparation material and documentation associated with material
  • Maintain control over materials in accordance with quarantine and release procedures
  • Create and maintain spreadsheets and databases to ensure consistent quality metric tracking and communication between departments
The essential requirements of the job include:
  • 1+ years of experience in a Quality, Auditing or Inspecting role
  • Experience working in a regulated or GMP compliant environment.
  • High School Diploma or equivalent GED required
It would be a plus if you also possess previous experience in:
  • Bachelor of Science; life science related field, preferred or equivalent experience
  • Dynamic 365 experience
  • LIMS or similar lab management systems


Shift Hours: Monday - Friday 3:00pm - 12:00 midnight

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.

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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