Quality Assurance Specialist - Quality Systems

Responsibilities

• Support and maintain Quality Systems including Deviations, CAPA, change control, document control, training, risk management, QA for QC, audits, and inspections
• Track implementation progress, monitor systems performance, and report status in governance forums
• Alert senior management of quality, compliance, and safety risks
• Provide guidance and training to employees on quality processes, procedures, and compliance expectations
• Support continuous improvement initiatives related to quality processes, systems, and compliance performance
• Act as site SME for Quality Systems, coordinating with global teams for alignment and best practices
• Lead and/or participate in inspection readiness preparation and execution
• Drive implementation of Quality Systems in compliance with Amgen Standards and Regulatory expectations

Requirements

• High school diploma / GED and 10 years of Quality or Operations experience OR
• Associate’s degree and 8 years of Quality or Operations experience OR
• Bachelor’s degree and 4 years of Quality or Operations experience OR
• Master’s degree and 2 years of Quality or Operations experience OR
• Doctorate degree

Preferred Qualifications

• Educational background in a science field
• Broad QA background supporting cross-functional quality operations
• Experience facilitating quality governance meetings
• Knowledge of risk management methodologies
• Understanding of regulations, standards, and guidelines associated with Quality Management Systems
• Experience participating in, managing, and/or responding to health authority inspections, partner, and corporate audits
• Strong organizational, problem-solving, and communication skills

Benefits

• Comprehensive employee benefits package including medical, dental, vision, life, and disability insurance
• Retirement and Savings Plan with generous company contributions
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans

About the Company

Amgen is a leading biotechnology company dedicated to unlocking the potential of biology to serve patients living with serious illnesses. Since 1980, Amgen has pioneered the biotech industry, focusing on therapeutic areas such as Oncology, Inflammation, General Medicine, and Rare Disease to deliver innovative medicines worldwide.