Specialist Quality Assurance (API)

• Provide Quality oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System in plant operations through phases of commissioning, process qualification, regulatory approval and market supply
• Support routine GMP documentation review activities (e.g. electronic batch records, SOPs, logbooks, work orders, batch production reports and validation protocols etc.) and ensure key performance indicator met targeted metrics
• Co-lead and support the deployment of Amgen quality systems, including management review, validation, change control and CAPA and ensure that the systems are managed in compliance with cGMP expectations
• Participate in complex root cause investigations for deviations
• Review and approve deviation investigations, change controls, and other quality records (with focus on highly complex records)
• Provides Quality Assurance support in New Product Introduction (NPI) team
• Coach site Quality Assurance professionals on resolution of complex problems
• Participate in regulatory inspections, and interact directly with regulatory inspectors
• Supporting other Quality Assurance initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation

• Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience
• 8 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical / biologics industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems
• Direct experience with bulk manufacturing of biopharmaceuticals/API preferred
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
• Experience with regulatory audits and inspections
• Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality

Direct experience with bulk manufacturing of biopharmaceuticals/API

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits