Senior Associate Quality Assurance – Night Shift

About the role

Amgen is seeking a Senior Associate in Quality Assurance (AML 14) to provide 24/7 on‑site support for manufacturing operations during night shifts. You will ensure that clinical and licensed pharmaceutical products are produced, tested, stored, and distributed in full compliance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (cGLP).

Key responsibilities

• Provide on‑site quality oversight for manufacturing areas, ensuring adherence to cGMP, cGLP, and other applicable regulations.
• Conduct continuous‑improvement initiatives, assess changes that may impact product quality, and investigate deviations.
• Review production records, batch records, and testing results for completeness and accuracy.
• Participate in internal plant audits, investigations, and triage/decision‑making processes.
• Execute sampling plans, manage SAP transactions, and handle queries in Trackwise and Veeva systems.
• Collaborate with operations to resolve basic compliance discrepancies.

Required profile

• Individual contributor with experience in pharmaceutical quality assurance.
• Familiarity with cGMP and cGLP requirements for clinical and licensed products.
• Ability to work non‑standard schedules, including nights, weekends, and holidays.
• Proactive engagement in continuous‑improvement projects.

Required skills

• cGMP compliance
• cGLP compliance
• SAP transaction handling
• Trackwise system usage
• Veeva system queries
• Sampling plan development and execution

What we offer

• Opportunity to contribute to life‑impacting biotech products.
• Collaborative, innovative, science‑driven culture.
• Professional growth within a global leader in biopharma.