Specialist Quality Assurance - Major Deviations

Career Category Quality Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist Quality Assurance – Major Deviations What you will do Let’s do this. Let’s change the world. In this vital role you will will serve as a Quality leader accountable for the investigation and resolution of major deviations, safeguarding product quality and patient safety through sound judgment, strong ownership, cross‑functional collaboration, and effective risk management in a dynamic drug product manufacturing environment. Specific responsibilities include but are not limited to: Serve as Quality investigation lead and decision-maker for major deviations, maintaining accountability for designation, documentation quality, timeliness and closure. Actively participate in deviation meetings, managing multiple concurrent deviations and driving effective resolution. Provide Quality oversight to ensure thorough documentation of deviations, including floor presence, process observation, and personnel interviews across shifts. Ensure that deviations 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 to be used as evidence for deviations are complete, accurate, and compliant with cGMP standards. Review, approve, and track cGMP documentation, including Deviations, procedure updates and associated records. Demonstrate strong critical thinking skills using evidence-based decision making. Use 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. Collaborate cross functionally with Manufacturing, Engineering, Validation, and Quality to ensure information required is complete and accurate. Escalate and communicate quality, compliance, supply, and patient safety risks to senior management as appropriate. Defend 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. Support Continuous Improvement initiatives, leveraging deviation learnings to strengthen systems and prevent recurrence. Complete required training and perform additional duties as assigned by management. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Specialist QA professional we seek is a Quality-driven professional with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of Quality Assurance experience OR Bachelor’s degree and 4 years of Quality Assurance experience OR Associate’s degree and 8 years of Quality Assurance experience OR High school diploma / GED and 10 years of Quality Assurance experience Preferred Qualifications: 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. What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance 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 and an annual site shutdown Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen