Senior Associate QA, International Distribution Quality

• Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation, as well as QA triage of Distribution complaints
• Work closely with all relevant collaborators for the end-to-end process and ensure compliance to GMP/GDP
• Expertise in quality assessment associated with transport temperature excursion management
• Expertise in assessing quality impacts of distribution deviations
• Hands-on experience in internal audits or self-inspections
• Demonstrated experience in batch disposition and release processes
• Act as subject matter expert (SME) for transportation related Quality Processes
• 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 the 3rd Parties to ensure adherence to service levels, identifying and implementing performance improvement
• Understand and incorporate risk management strategy into overall supply chain strategy
• Provide support for logistic service provider and transportation service provider oversight
• Support in tactical activities for internal/external audits and inspections as part of the audit/inspection team
• Provide quality expertise and guidance to operational staff and within cross functional Amgen teams
• 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

• Bachelor’s degree in science or engineering and 2+ years of professional experience in related fields
• Understanding of GMP/GDP requirements
• Familiarity with logistics processes of parcel, transport, and warehousing providers
• Experience in Validation/Qualification of processes, equipment, and facilities
• Strong technical writing skills

• Global Supply Quality Background
• Distribution Quality background
• Strong continuous improvement attitude 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, Power BI and smart sheet
• Ability to multi-task and prioritize

competitive and comprehensive Total Rewards Plans