OQA Lead

About the role

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Aldevron, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s 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, 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. 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.

Responsibilities

• 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.
• 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.

Requirements

• High 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.

Preferred Qualifications

• Previous experience working in a GMP environment that emphasizes Good Documentation Practices (GDP).
• Review of Quality documentation such as batch records, laboratory records, deviations, investigations, and change controls.
• Previous bioengineering Quality field centered around data integrity and ALCOA++ principles.

Benefits

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.