OQA Lead

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

AtAldevron one ofDanahers15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessingDanahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

At Aldevron we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers.As a member of our team youll help bring life-changing innovations to lifeimpacting millions around the world. We bring together deep scientific expertise an unwavering commitment to quality and a collaborative spirit to drive progress. Whether youre launching your career or bringing years of experience we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potentialone discovery at a time.

Learn about theDanaher Business Systemwhich makes everything possible.

TheOQA Leadis responsibleforexecuting 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 positionreports to the second shift OQASupervisor andis part of theQuality Assurance department located in Fargo ND and will be an on-site role.

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.

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

Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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