Specialist QA - Major Deviations

• Provide Quality oversight to ensure clinical and commercial pharmaceutical products are manufactured, tested, stored, and distributed in compliance with cGMP and applicable regulations
• Serve as Quality investigation lead and decision-maker for complex Major Deviations, maintaining accountability for investigation quality, timelines, documentation, and closure
• Actively participate in deviation and RCA meetings, managing multiple concurrent deviations and driving effective resolution
• Conduct thorough root cause investigations, including floor presence, process observation, and personnel interviews across shifts, including nights when required
• Review, approve, and track cGMP documentation, including Deviations, CAPAs, CAPA Effectiveness Verification (EV), Change Controls, validations, and associated records
• Demonstrate strong critical thinking skills, the ability to distinguish causal factors from root causes, and the ability to evaluate investigation quality using evidence-based decision making
• Ensure that changes with potential impact to product quality are properly assessed and documented per established procedures
• Verify that deviations from established procedures are investigated, documented, and resolved in accordance with Quality System requirements
• Ensure production records, laboratory results, and investigation documentation are complete, accurate, and compliant with cGMP standards
• Collaborate cross‑functionally with Manufacturing, Engineering, Validation, and Quality to implement effective and sustainable CAPAs
• Escalate and communicate quality, compliance, supply, and patient safety risks to senior management as appropriate
• Defend investigation strategies, root cause conclusions, CAPA plans, and product impact assessments during internal audits, regulatory inspections, and leadership review forums
• Maintain flexibility to support network interactions across time zones and operational needs requiring schedule adaptability
• Support Continuous Improvement initiatives, leveraging deviation learnings to strengthen systems and prevent recurrence
• Complete required training and perform additional duties as assigned by management

Doctorate degree OR Master's degree and 2 years of Manufacturing Support and/or Quality Assurance experience OR Bachelor's degree and 4 years of Manufacturing Support and/or Quality Assurance experience OR Associate's degree and 8 years of Manufacturing Support and/or Quality Assurance experience OR High school diploma / GED and 10 years of Manufacturing Support and/or Quality Assurance experience

• Advanced experience in Quality Systems, with demonstrated expertise in Major Deviations, CAPA, and CAPA Effectiveness Verification (EV) within a regulated GxP environment
• Proven ability to lead and own complex root cause investigations, including facilitating RCA discussions and driving cross‑functional alignment
• Proficient technical writing skills with the ability to produce concise, objective, evidence-based, inspection-ready documentation in compliance with ALCOA+ and Good Documentation Practices
• Strong sense of accountability and ownership, with the ability to manage multiple high‑impact deviations simultaneously and deliver timely, compliant outcomes
• Demonstrated ability to evaluate compliance issues, perform advanced data trending and analysis, and assess systemic quality risks
• Ability to identify systemic quality signals, recurring failure modes, and cross-functional process vulnerabilities through trend analysis and prior occurrence assessment
• Experience engaging directly with manufacturing operations, including floor support, process observation, and personnel interviews across multiple shifts
• Proven experience supporting regulatory inspections and audits, including demonstrated ability to interact with regulatory agencies
• Technically savvy and adaptable, with openness to leveraging digital tools, automation, and emerging technologies (including AI‑enabled tools) to improve investigation effectiveness
• Flexibility to support variable schedules and cross‑time‑zone interactions, while consistently demonstrating Amgen Values and Leadership Practices

• Health and welfare plans for staff and eligible dependents
• Financial plans with opportunities to save towards retirement or other goals
• Work/life balance
• Career development opportunities
• Retirement and Savings Plan with generous company contributions
• Group medical, dental & vision coverage
• Life & disability insurance
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans and an annual site shutdown
• Flexible work models, including remote work arrangements, where possible