Sr Associate Supplier Quality

Working independently, the individual will be responsible for, but not limited to the following:

• Perform QA Contact role on the 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, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations
• Collaborate with raw material suppliers to ensure alignment 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
• Work under minimal supervision in line with Amgen Values and Leadership Attributes

• We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications:
• Bachelors degree in science or engineering and 2+ years of professional experience in related fields
• Understanding of GMP/GDP requirements
• Familiarity with raw material compendial testing
• Experience overseeing quality of suppliers or external parties
• Deep technical writing skills

• Strong continuous improvement approach and lean practices experience
• Understanding of end-to-end supply chain business processes
• Experience in project management across multiple departments and geographies
• Quick process understanding, insight and visualizing
• Strong analytical and problem-solving skills
• Independent self-starter, able to work autonomously, under pressure and in teams
• GMP/GDP knowledge and understanding of pharmaceutical regulations
• Energetic, detail oriented, highly motivated with a can do outlook
• Change management skills
• Ability to communicate across all levels of the organization
• Effective written and verbal communication skills
• Experience with Microsoft Office Tools including Excel, Word, and PowerPoint
• Ability to multi-task and prioritize