Senior Associate Quality Assurance - Global Supply Quality

Join Amgen's mission to serve patients by working as a Senior Associate Quality Assurance in Global Supply Quality. The role involves overseeing quality and compliance of raw material suppliers, collaborating with stakeholders, and ensuring adherence to GMP/GDP regulations.

Requirements

• Perform QA Contact role on Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation
• Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP
• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements
• Collaborate with raw material suppliers to ensure adherence to quality agreements, identifying performance improvement opportunities
• Understand and incorporate risk management strategy into the overall raw material lifecycle
• Provide support to the supplier periodic monitoring oversight activities
• Support in tactical activities related to internal/external audits and inspections
• Perform routine quality assessments and provide approval of changes to raw material inspection profiles
• Take part in operational improvement initiatives, programs, and projects
• Develop solutions that are thorough, practical, and consistent with functional objectives
• Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships

Benefits

• Competitive and comprehensive Total Rewards Plans
• Inclusive environment of diverse, ethical, committed and highly accomplished people
• Opportunities for professional and personal growth and well-being
• Equal Opportunity employer