Specialist Quality Assurance - Global Supply Quality

You will make key contributions to ensure high-quality and right-first-time materials are received at Amgen, build a resilient supply network, and conclude with a positive patient experience.

In this role, you will be part of Amgen's Global Supply Quality team, supporting oversight and maintenance of external suppliers and contract manufacturers.

Roles & Responsibilities :

• Periodic review and updates to quality agreements to ensure alignment with Amgen expectations and to address needs depending on material type.
• Documentation review and approval, including supplier records, investigation reports, Amgen quality records, and validation records.
• Evaluation and documentation of raw materials and devices for changes to incoming inspection profiles.
• Oversight and completion of supplier assessments and documentation to support product complaints.
• Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships.
• Review and approval of change control records for supplier changes.
• Management of supplier audit records, ensuring on-time completion and CAPA closeout activities are documented with appropriate closeout evidence.
• 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.
• Take part in operational and quality improvement initiatives, programs, and projects.
• Develop solutions that are thorough, practical, and consistent with functional objectives.
• This role may require working in shifts or extended hours within the same shift to support global time zones.

What we expect of you

Basic Qualifications :

Preferred Qualifications :

Must-Have Skills :

Good-to-Have Skills :

Soft Skills :

Skills Required

Cgmp, Troubleshooting, Qms, Regulatory Requirements, Quality Assurance, Capa