Specialist QA - Product Disposition Support

About the role

The AIN Specialist QA supports product disposition-related tasks across the Amgen Quality Operations Network, covering product expiry management, product complaints, disposition manager training and data requests. The role is based in the Amgen India office in Hyderabad and may involve leading a shift-based team that covers multiple time zones, with some work outside normal hours.

Key responsibilities

• Extend shelf life of DSI/DS/DP material through the GMP process and update batch expiry dates in the SAP inventory system
• Evaluate and approve or reject expiry-SAF forms
• Support partner requests for data on product batches, recover data from systems such as MES, QC LIMS, RIM and SAP, and share it with partners
• Generate Certificates of Analysis (CoA) and share documentation with partners, regulators and process developers
• Deliver quality systems training to new disposition managers virtually, covering ERP/SAP, MES/EBR, ARRS, LIMS, CDOCS, DQMS, Kneat and others, and maintain training materials in the controlled documents system
• Review full batch records for complaints, assess electronic batch records in the MES and record results in the Bioconnect quality system

Required profile

• Master's degree with 8-12 years of pharma and biotech commercial or clinical manufacturing quality experience
• Experience in manufacturing environments and in regulated environments with GMP and GDP knowledge
• Experience with quality systems such as ERP/SAP, RIM, CDOCS, change control, deviation handling and QC LIMS
• Staff training and development experience
• Preferred: project management experience, technical writing and data visualization (Smartsheet, Tableau or similar)