Join Amgen's mission to serve patients by supporting product disposition related tasks across the Amgen Quality Operations 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)
- Disposition Support of Partner Requests
- Data recovery from systems
- Uploading and communication of collected data to Amgen partners
- COA Generation, special requests after disposition
- 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
- Disposition Manager Training
- Execution and delivery of quality systems training to new disposition managers across the Amgen network via virtual meetings
- Maintenance and revision of training document materials in the controlled documents management system (CDOCs)
- Product Complaints
- 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
- Recording the results of the complaints batch record assessment in the Bioconnect quality system
