QA Release & Validation Specialist

Danaher•Fargo, ND

1d•Onsite

About The Position

The QA Release & Validation Specialist is responsible for reviewing & approving executed batch records & batch disposition, QC testing assays, and 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. In this role, you will have the opportunity to 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. You will also 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.

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.