Senior Associate QA, International Distribution Quality
Core
Implement and oversee global product distribution and transportation from Amgen's Global Supply Hubs to global markets, providing QA oversight for Global Supply Chain operations.
Role type
Senior Associate Quality Assurance (Supply Chain/Distribution)
Builds
Global pharmaceutical supply chain distribution and transportation networks
Domain
Biotechnology / Pharmaceutical Supply Chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GDP compliance, logistics process management, validation/qualification of processes and equipment, technical writing, batch disposition and release, internal audit execution, risk management strategy, supplier performance assessment
Preferred skills
Global supply quality background, distribution quality experience, continuous improvement/lean practices, end-to-end supply chain knowledge, project management, analytical problem-solving, change management
Technologies
Microsoft Office (Excel, Word, PowerPoint), Power BI, SharePoint
Responsibilities
Perform QA contact role on quality events, change controls, CAPAs, and distribution complaints; oversee transport temperature excursion management; assess quality impacts of distribution deviations; prepare and approve SOPs and GMP/GDP documentation; collaborate with third parties to ensure service level adherence; support internal/external audits; provide quality guidance to operational staff; own supplier metrics and performance assessments
Seniority
Senior, hands-on IC
