Specialist Quality Assurance (Technical Support)

About the role

Amgen is looking for a Specialist Quality Assurance to provide oversight and leadership for quality systems execution and operations support across Facilities & Engineering, Quality Control, Technology, Process Development and Validation (non-manufacturing areas) of its Biologics and Synthetic Manufacturing plants. The role covers commissioning, qualification, regulatory approval and market supply.

Key responsibilities

• Ensure GMP compliance and the Amgen Quality Management System are applied correctly during commissioning, qualification, regulatory approval and market supply
• Support routine GMP documentation review (SOPs, logbooks, work orders, validation documents) and track KPIs
• Help deploy quality systems such as management review, validation, deviation, change control and CAPA in line with cGMP
• Review and approve deviations, investigations, change controls and other quality records, and lead complex root cause investigations
• Lead QA oversight in commissioning, qualification and NPI projects, and coach site QA professionals
• Take part in regulatory inspections and lead or support continuous improvement initiatives

Required profile

• Doctorate, or Master's degree with 2 years' experience in a pharma or GMP environment, or Bachelor's degree with 4 years' experience
• Or diploma with 8 years' experience in a pharma or GMP environment
• Preferred: 8 years in manufacturing, process development or quality assurance in the biologics industry, with regulatory audit experience and direct experience with bulk manufacturing of biopharmaceuticals/API
• Medical requirements of the job scope must be fulfilled

Required skills

• Proficiency in written and verbal communication, including technical writing and presentations
• Problem-solving and data assessment for compliance and product quality
• Project management and quality systems experience preferred