Quality Assurance Associate

AtomVie Global Radiopharma Inc.

About the Role

The QA Associate for Batch Release is responsible for final disposition of incoming materials and final radiopharmaceutical drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements.

What You Will Do

• Determine final disposition of batches by reviewing all required documentation, including but not limited to batch records and change controls, and determining the status of deviations
• Complete media fill reviews, reporting any issues
• Participate in the creation and revision of standard operating procedures, and specifications
• Review Certificates of Analysis, material management or other similar documentation for internal and external customers
• Release incoming materials (e.g. activity, raw materia...