QA Release Specialist II — Remote-Eligible Life Sciences

Danaher Corporation; United States; Remote; USD 65,000 - 90,000; Full time

Job summary

Aldevron, a Danaher operating company, is seeking a QA Release Specialist II to join the on-site team in Fargo, ND. You will review batch documentation, evaluate CPPs and CQAs, and ensure regulatory compliance to support final release.

In this role you’ll collaborate with QA, Quality Control, Operations, and Manufacturing to facilitate documentation review, correction, finalization, and disposition activities, while contributing to continuous improvement of quality systems.

Qualifications

• 1+ year in a Quality or auditing role in a GMP environment.
• BS degree preferred in life sciences or equivalent experience.
• Strong communication, critical thinking and decision-making skills.

Responsibilities

• Serve as QA SME in review and disposition of materials and products, including final batch release.
• Collaborate with QA, QC, Operations, and Manufacturing to review, correct, finalize and disposition documents.
• Support continuous improvement by tracking errors and contributing to work instructions and procedures.

Skills

Quality assurance

Auditing

Documentation review

Regulatory compliance

Education

Bachelor of Science (Life science preferred)

Equivalent work experience

Job description

Aldevron, a Danaher operating company, is seeking a QA Release Specialist II to join the on-site team in Fargo, ND. You will review batch documentation, evaluate CPPs and CQAs, and ensure regulatory compliance to support final release.

In this role you’ll collaborate with QA, Quality Control, Operations, and Manufacturing to facilitate documentation review, correction, finalization, and disposition activities, while contributing to continuous improvement of quality systems.