QA Release Specialist II — cGMP & Batch Release

Danaher; Fargo (ND); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Remote work arrangement

Job summary

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

You will collaborate with Quality Assurance, Quality Control, Operations, and other functions to ensure timely disposition and continuous quality improvements across documentation and processes.

Qualifications

• Minimum of 1 year experience in a Quality or auditing role in a regulated or GMP environment.
• Bachelor of Science preferred, life science discipline, or equivalent experience.
• Strong communication, critical thinking, and decision-making skills; ability to work independently and with teams.

Responsibilities

• Review and evaluate batch documentation, production records, testing records for compliance and completeness.
• Evaluate CPPs, CQAs and other requirements to support material disposition and release.
• Identify and escalate quality issues impacting product quality, safety, compliance or release.
• Report to QA Release Supervisor; be part of the QA Release team on-site in Fargo, ND.

Skills

Quality experience

Auditing

Regulatory compliance

Communication

Education

Bachelor's in Life Science

Job description

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

You will collaborate with Quality Assurance, Quality Control, Operations, and other functions to ensure timely disposition and continuous quality improvements across documentation and processes.