Senior Associate QA, Global Distribution Quality

The Sr. Associate QA position will implement and oversee global product distribution and transportation from Amgens Global Supply Hubs to Amgens global markets, and provide QA oversight of QA activities for Global Supply Chain operations.

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, as well as QA triage of Distribution complaints.
• Work closely with all relevant stakeholders for the end-to-end process and ensure compliance to GMP/GDP.
• 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

• 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 logistics processes of parcel, transport, and warehousing providers.
• Experience in Validation/Qualification of processes, equipment, and facilities.
• Strong technical writing skills.

• Strong continuous improvement mindset 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