Temporary Data Reviewer

Key Responsibilities

• Review Batch Records, In-Process and Release testing data, Chain of Custody forms, Receiving Inspections, Thawing and Infusion documentation related to GMP and Non-GMP batch releases.
• Scan and archive QA reviewed batch data.
• Optimize the eQMS batch release system including updating SOPs and paper forms.
• Monitor batch disposition compliance, metrics, and effectiveness

Qualifications

• Minimum Qualifications: Bachelor's degree in a scientific discipline or related field, or an equivalent combination of education and relevant experience. Minimum of three (3) years of experience data review in a GMP regulated life sciences environment.
• Preferred Qualifications: Experience developing GMP QA systems specifically batch release and disposition. Knowledge of FDA cGMP regulations, FACT standards, and GMP documentation practices.