Specialist QA, Global Supply Quality

Job Description:

Responsibilities

• Periodic review and updates to quality agreements to ensure alignment to Amgen expectations and to address needs depending on material type.
• Documentation review and approval including: supplier manufacturing records, investigation reports, Amgen quality records, and validation records (process & analytical) .
• 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.

Qualification & Experience

• Master’s degree with 10 years of experience in manufacturing and quality management systems or a related field OR
• Bachelor’s degree with 12 to 13 years of experience in quality management systems or a related field