Specialist QA – Biopharmaceutical

About the role

Amgen is looking for a Specialist QA to support its Quality Assurance program at the Juncos, Puerto Rico site. The role focuses on reviewing and approving manufacturing documentation, leading investigations, and ensuring compliance with cGMP standards in a biopharmaceutical environment.

Key responsibilities

• Review and approve product manufacturing procedures (MPs) and process validation protocols.
• Approve environmental characterization reports, sanitary utility system releases, and planned incidents.
• Represent QA on New Product Introduction (NPI) teams and lead site audits.
• Lead investigations, CAPA records, change controls, and NC investigations.
• Own site quality program procedures and act as designee for the QA manager on the local CCRB.
• Support automation, facilities, environmental programs, and risk assessments.
• Review and approve work orders, EMS/BMS alarms, and lot disposition for shipment.

Required profile

• Doctorate or Master’s degree with at least 2 years of directly related experience, or Bachelor’s with 4 years, Associate’s with 8 years, or High School/GED with 10 years.
• Demonstrated ability to perform on‑floor Plant Quality Assurance reviews and manage cGMP documentation.
• Experience leading investigations, audits, and continuous‑improvement projects.

Required skills

• cGMP compliance
• MES (Manufacturing Execution System)
• EBR (Electronic Batch Record)
• SAP
• EDMQ
• DQMS
• Trackwise
• Automation activities
• Computer systems validation
• Change control management
• CAPA (Corrective and Preventive Action) handling
• Deviation management
• Validation processes
• Risk assessment
• Environmental characterization
• Sanitary utility system release
• Audit and inspection management
• New Product Introduction (NPI) support