Specialist QA

Join Amgen's mission to serve patients by 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, and fulfillment of disposition related data requests across the network.

Requirements

• DSI/DS/DP material shelf-life extension
• 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
• Data recovery from systems including, but not limited to, manufacturing execution system electronic batch records, the quality control laboratory information system, the regulatory information management system, and the Amgen enterprise resource management system (SAP)
• Uploading and communication of collected data to Amgen partners
• Generation and provision of Certificate of Analysis (CofA) records for Amgen drug substance, drug product, or final drug product batches
• Uploading and communication of collected documentation to requestor
• Execution and delivery of quality systems training to new disposition managers across the Amgen network via virtual meetings
• Assessing electronic batch record (EBRs) documentation in the manufacturing execution system (MES) to identify any potential issues relevant to the complaint
• Recording the results of the complaints batch record assessment in the Bioconnect quality system

Benefits

• Competitive salary
• Comprehensive benefits package
• Opportunities for professional growth and development