Specialist Quality Assurance - Major Deviations

What we expect of you

Preferred Qualificationsnice to have

• Academic degree in Microbiology, Engineering, Chemistry, or a related scientific field. Experience supporting drug product operations in a GMP-regulated environment.
• Advanced experience in Quality Systems, with demonstrated expertise documenting Deviations, CAPA, and CAPA Effectiveness Verification (EV) within a regulated GxP environment.
• Proven ability to lead root cause investigations, facilitate RCA discussions, influence others, and drive cross-functional alignment.
• Demonstrated accountability and ownership in managing multiple high-impact deviations and delivering timely, compliant outcomes.
• Demonstrated ability to evaluate compliance issues and use trend analysis and prior occurrence assessments to identify systemic quality signals, recurring failure modes, process vulnerabilities, and quality risks.
• 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 and contributing to successful inspection outcomes.
• Proficient technical writing skills with the ability to produce concise, objective, evidence-based, inspection-ready documentation in compliance with ALCOA+ and Good Documentation Practices.
• Technically savvy and adaptable, with openness to using 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.

Specific responsibilities include but are not limited to

1. 1Serve as Quality investigation lead and decision-maker for major deviations, maintaining accountability for designation, documentation quality, timeliness and closure.
2. 2Actively participate in deviation meetings, managing multiple concurrent deviations and driving effective resolution.
3. 3Provide Quality oversight to ensure thorough documentation of deviations, including floor presence, process observation, and personnel interviews across shifts.
4. 4Ensure that deviations with potential impact to product quality are properly assessed and documented per established procedures.
5. 5Verify that deviations from established procedures are investigated, documented, and resolved in accordance with Quality System requirements.
6. 6Ensure production records, laboratory results, and investigation documentation to be used as evidence for deviations are complete, accurate, and compliant with cGMP standards.
7. 7Review, approve, and track cGMP documentation, including Deviations, procedure updates and associated records.
8. 8Demonstrate strong critical thinking skills using evidence-based decision making.
9. 9Use approved AI tools, as applicable, to support major deviation activities, such as reviewing records, organizing evidence, identifying trends, and drafting investigation content. Verify AI-generated outputs for accuracy and maintain accountability for decisions and final documentation.
10. 10Collaborate cross functionally with Manufacturing, Engineering, Validation, and Quality to ensure information required is complete and accurate.
11. 11Escalate and communicate quality, compliance, supply, and patient safety risks to senior management as appropriate.
12. 12Defend deviations during internal audits, regulatory inspections, and leadership review forums. Maintain flexibility to support network interactions across time zones and operational needs requiring schedule adaptability.
13. 13Support Continuous Improvement initiatives, leveraging deviation learnings to strengthen systems and prevent recurrence.
14. 14Complete required training and perform additional duties as assigned by management.