OQA Lead - Second Shift

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The OQA Lead is responsible for executing batch record review, ensuring Good Manufacturing Practices (GMP) are met, troubleshooting manufacturing events, partaking in deviation investigations, and associated duties that support accurate and reliable batch record generation.

This position reports to the second shift OQA Supervisor and is part of the Quality Assurance department located in Fargo, ND and will be an on-site role. 

SHIFT: Second Shift: M-Th 3:30pm-2:00am

In this role, you will have the opportunity to:

• Independently perform batch record review of documents generated within GMP manufacturing.

• Assess GMP documents for quality and accuracy, and play an integral role in investigations into deviations that may present themselves during GMP activities.

• Assist with tasks associated with overall completion of GMP manufacturing.

The essential requirements of the job include: 

• Hish school diploma. Bachelor of Science in Biology, Microbiology, or related work experience preferred.

• Independently perform batch record review as assigned.

• Accurate and timely review of documentation with the ability to assess documentation and GMP activities for quality standards upheld by Aldevron.

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

• Working in a GMP environment that emphasizes Good Documentation Practices (GDP).

• Review of Quality documentation such as batch records, laboratory records, deviations, investigation, and change controls.

• A previous bioengineering Quality field centered around data integrity and ALCOA++ principles.

Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

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.

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.