OQA Lead

Danaher•Fargo, ND

10d•Onsite

About The Position

Aldevron, a Danaher operating company, delivers 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, you’ll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're 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 potential—one discovery at a time. Learn about the Danaher Business System which makes everything possible.

Requirements

Hish school diploma.
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.

Nice To Haves

Bachelor of Science in Biology, Microbiology, or related work experience preferred.
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.

Responsibilities

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.
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.