Specialist QA

The AIN Specialist QA plays a critical role in supporting product disposition related tasks across the Amgen Quality Operations Network. The Specialist QA will leverage industry, technical, and quality systems knowledge to provide support of product expiry management processes, product complaints processes, disposition manager training, and fulfillment of disposition related data requests across the network.

Requirements

• Executing the GMP process to extend expiration dates for clinical and commercial products produced at Amgen.
• Updating batch product expiration dates in the Amgen SAP inventory management system.
• Evaluating (approve or reject) expiry-SAF forms (expiry stability assessment forms).
• Support requests made by Amgen partners for data and information related to their partnered product batches manufactured at Amgen sites.
• Generation and provision of Certificate of Analysis (CofA) records for Amgen drug substance, drug product, or final drug product batches.
• Execution and delivery of quality systems training to new disposition managers across the Amgen network via virtual meetings.
• Execution of the drug substance, drug product, and final drug product complaint full batch record review process.
• Assessing electronic batch record (EBRs) documentation in the manufacturing execution system (MES) to identify any potential issues relevant to the complaint.