Drug Substance Quality Assurance Specialist

• Provides Quality oversight, review, and approval of major deviation investigations, ensuring events are thoroughly investigated, appropriately documented, and resolved in accordance with regulatory requirements and site procedures
• Partners with Manufacturing, Facilities & Engineering, Quality Control, and other cross-functional stakeholders to facilitate root cause analyses, risk assessments, corrective and preventive actions (CAPAs), and effectiveness verification activities
• Maintains the safety of self and others, actively engages with the Amgen EHSS safety program by reporting unsafe conditions if seen and driving improvements
• Observes GMP operations within a clean room environment and providing constructive feedback to staff and managers
• Reviews and provides Quality approval for GMP documentation such as revisions to procedures and GMP documents, investigation reports for major deviations, change control records, corrective action / preventive action records, and other GMP records
• Identifies and escalates significant quality, compliance, supply, and safety risks to management and supports risk-based decision making
• Contribute to and drive digital innovation solutions and applications in cross-functional collaboration
• Participates as a QA team member process during regulatory inspections, third party audits, and internal audits
• Makes certain the Quality Management System processes are executed in accordance with established procedures
• May author and own cGMP documents and reports
• May also perform other duties as assigned

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

• Excellent interpersonal skills
• Excellent written and verbal communication skills
• ability to work in a team matrix environment and build relationships with partners
• Strong experience supporting deviation investigations
• root cause analysis
• CAPA development
• and Quality Management System processes
• Knowledge of contamination control strategies
• environmental monitoring programs
• and utility monitoring systems within GMP manufacturing environments
• Experience supporting or partnering with microbiology laboratories
• environmental monitoring programs
• aseptic operations
• or contamination investigations
• Direct experience driving process improvements
• Working knowledge of Lean and Six Sigma methodologies a plus
• Experience participating in
• managing
• and responding to corporate audits/regulatory inspections
• Experience with Quality Management Systems
• including Change Control
• and Risk Management
• Demonstrated ability with project management
• initiating and leading cross-functional teams
• leading and managing change
• Biology
• Chemistry
• or Engineering degree is desirable

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible