GMP Batch Records QA Lead

Radiometer; Fargo (ND); On-site; USD 70,000 - 110,000; Full time

Job summary

Aldevron in Fargo, ND is seeking an OQA Lead to oversee batch record review and GMP compliance to support our GMP manufacturing operations. This on-site role reports to the OQA Supervisor in the Quality Assurance department and focuses on ensuring accurate batch documentation and timely investigations.

You will independently review GMP documents, participate in deviation investigations, and assist with GMP manufacturing activities to uphold Danaher standards of quality and continuous improvement.

Qualifications

• Bachelor of Science in Biology, Microbiology, or related work experience preferred.
• High school diploma required.
• Experience with batch record review and GMP documentation is a plus.

Responsibilities

• Independently perform batch record review of GMP documents.
• Assess GMP documents for quality and accuracy; participate in deviation investigations.
• Assist with GMP manufacturing tasks to ensure compliance and timely production.

Skills

Batch record review

GMP compliance

Quality Assurance

Investigations

Education

High school diploma

Bachelor of Science in Biology or Microbiology

Job description

Aldevron in Fargo, ND is seeking an OQA Lead to oversee batch record review and GMP compliance to support our GMP manufacturing operations. This on-site role reports to the OQA Supervisor in the Quality Assurance department and focuses on ensuring accurate batch documentation and timely investigations.

You will independently review GMP documents, participate in deviation investigations, and assist with GMP manufacturing activities to uphold Danaher standards of quality and continuous improvement.