Drug Product Quality Assurance Specialist

• Partners with Manufacturing, Facilities & Engineering, Quality Control, and other cross-functional stakeholders to facilitate root cause analyses, risk assessments, CAPAs, and effectiveness verification activities
• Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations
• Partners with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards
• Provides Quality Oversight of the manufacturing facility including manufacturing operations, inspection and utilities, as well as nonroutine activities such as process and product validation
• Provides quality expertise and guidance to operational staff and within cross functional Amgen teams
• Reviews and approves controlled documents, including but not limited to Standard Operating Procedures, Protocols and Reports
• Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
• Participates in Amgen internal/external audits and inspections
• Directly interacts with regulatory agencies during on-site inspections
• Contributes to and drives continuous improvement projects in cross-functional collaboration
• Represents the Quality function and provides quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals
• Contributes to and drives digital innovation solutions and applications in cross-functional collaboration

Doctorate degree OR Master's degree and 2 years of quality experience OR Bachelor's degree and 4 years of quality experience OR Associate's degree and 8 years of quality experience OR High school diploma / GED and 10 years of quality experience

• Bachelor's Degree in Science
• 5 plus years of aseptic processing experience in QA or Manufacturing
• Strong experience supporting deviation investigations, root cause analysis, CAPA development, and Quality Management System processes such as Change Control and Risk Management
• Knowledge of contamination control strategies, environmental monitoring programs, and utility monitoring systems within GMP manufacturing environments
• Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners at all levels within the Organization
• Strong level of analysis skills to evaluate and interpret information to arrive at logical and quality-minded conclusions
• Experience applying problem solving tools for root cause analysis
• Experience participating in, managing, and responding to corporate audits/regulatory inspections
• Demonstrated ability with project management, initiating and leading cross-functional teams, leading and managing change

• Retirement and Savings Plan with generous company contributions
• group medical, dental and vision coverage
• life and disability insurance
• flexible spending accounts
• discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans