OQA Lead
Danaher · Fargo, ND
QualityFull-timeCompany career page
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Role summary
Aldevron, a Danaher operating company, seeks an OQA Lead to perform batch record reviews and ensure GMP compliance in a CDMO manufacturing environment. The role involves document assessment, deviation investigation support, and quality assurance duties at the Fargo, North Dakota facility.
What they're looking for
- High school diploma minimum; Bachelor of Science in Biology, Microbiology, or related field preferred
- Ability to independently perform batch record review and assessment
- Strong attention to detail and timely documentation review skills
- Experience working in GMP environment with Good Documentation Practices emphasis
- Knowledge of batch records, laboratory records, deviations, investigations, and change controls
- Familiarity with data integrity and ALCOA++ principles in quality context
What you'll be doing
- Independently review and assess batch records generated during GMP manufacturing operations
- Evaluate GMP documentation for quality, accuracy, and compliance with company standards
- Participate in deviation investigations and support troubleshooting of manufacturing events
- Assist with tasks related to completion of GMP manufacturing activities
Privacy & handoff
This role links to Danaher's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.