QA Release & Validation Specialist

Danaher Corporation•Fargo, ND

3d•$43,500 - $72,000•Onsite

About The Position

Aldevron, one of Danaher’s operating companies, delivers world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you’ll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential—one discovery at a time. Learn about the Danaher Business System which makes everything possible. The QA Release & Validation Specialist is responsible for reviewing & approving the following: Executed batch records & batch disposition QC testing assays Executed validation documentation This position reports to the QA Release Supervisor and is part of the QA Release team within the Operational QA organization located in Fargo, ND and will be an on-site role.

Requirements

A minimum of one (1) year of experience in a Quality or auditing role
Experience working in a regulated or GMP-compliant environment.
Bachelor of Science or life science discipline preferred or equivalent experience.
Ability to use computer, monitor, headset, mouse/keyboard, sit/stand desk, and copier/scanner.
Ability to lift, move or carry equipment up to 50lbs.

Nice To Haves

US Code of Federal Regulations (CFR) and/or EU Regulations
cGMP

Responsibilities

Review production and test records for completeness and accuracy, ensuring data supports release, meets SOP and applicable Regulations, and all deviations have been appropriately investigated and resolved.
Review Equipment, Process, Computer Validation, and Bioanalytical Method Development Validation executed documentation to ensure compliance with approved protocols, quality standards, and applicable Regulations.
Serve as the QA subject matter expert and ensure products, testing, and validation activities not meeting specifications are dispositioned appropriately.