OQA Lead - Second Shift Job at Danaher, Fargo, ND

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  • Danaher
  • Fargo, ND

Job Description

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

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