OQA Lead - Second Shift
Danaher Corporation Office Usa
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 4 days ago
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