Senior Associate QA, Global Distribution Quality (GDQ)

What you will do

We are seeking a highly motivated individual for our Global Distribution Quality (GDQ) team. This is an incredibly exciting opportunity to join a team of quality professionals in global distribution team. 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, as well as QA triage of Distribution complaints.
• Work closely with all relevant partners for the end-to-end process and ensure compliance to GMP/GDP.
• Act as subject matter expert (SME) for transportation related Quality Processes
• Collaborate with the 3rd Parties to ensure alignment to service levels, identifying and implementing performance improvement
• 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
• 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 multi-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

What we expect of you

Basic Qualifications and Experience

• 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:
• 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.
• Deep technical writing 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