Drug Product Quality Assurance Specialist

About the role

Amgen is hiring a Drug Product Quality Assurance Specialist for its Plant Quality Assurance organization in Thousand Oaks. The specialist provides quality oversight of operational activities in aseptic drug product manufacturing and inspection, working under minimal supervision to ensure adherence to cGMP requirements, quality systems and regulatory expectations. The role partners with Manufacturing, Facilities & Engineering, Quality Control and other cross-functional teams.

Key responsibilities

• Ensure timely completion of Quality Management System records, including deviations, CAPAs, change controls and document revisions, and review and approve controlled documents such as SOPs, protocols and reports
• Facilitate root cause analyses, risk assessments, CAPAs and effectiveness verification, and investigate and resolve quality events in line with regulatory requirements
• Provide quality oversight of manufacturing operations, inspection, utilities and nonroutine activities such as process and product validation
• Take part in internal and external audits and inspections, and interact directly with regulatory agencies during on-site inspections
• Contribute to continuous improvement and digital innovation projects, representing the Quality function across departments

Required profile

• Basic qualification: doctorate, or master's degree with 2 years of quality experience, or bachelor's degree with 4 years, or associate's degree with 8 years, or high school diploma with 10 years of quality experience
• Preferred: bachelor's degree in science and 5+ years of aseptic processing experience in QA or manufacturing
• Experience with deviation investigations, root cause analysis, CAPA development, change control and risk management
• Experience with project management, leading cross-functional teams and managing change

Required skills

• Knowledge of contamination control strategies, environmental monitoring and utility monitoring systems in GMP environments
• Problem-solving tools for root cause analysis
• Excellent written and verbal communication and teamwork skills

What we offer

• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Award-winning time-off plans and flexible work models where possible