OQA Lead
About The Position
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.
Requirements
- Hish school diploma
- Bachelor of Science in Biology, Microbiology, or related work experience preferred
Nice To Haves
- 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
- Executing batch record review
- Ensuring Good Manufacturing Practices (GMP) are met
- Troubleshooting manufacturing events
- Partaking in deviation investigations
- 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
- 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
- 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
Benefits
- Health care program
- Paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
