Specialist Quality Assurance - Major Deviations

Amgen; Puerto Rico; On-site; USD 110,000 - 160,000; Full time

Job summary

Amgen seeks a Specialist Quality Assurance to lead major deviation investigations, ensuring product quality and patient safety in a GMP environment. You'll drive cross-functional collaboration with Manufacturing, Engineering, Validation, and Quality to resolve deviations and prevent recurrence.

Responsibilities include leading investigations, documenting outcomes, and escalating risks as needed. Strong root-cause and CAPA experience are essential, with a focus on data-driven decisions.

Qualifications

• We are seeking a quality-driven professional with ownership and accountability.
• Experience documenting Deviations, CAPA, and CAPA Effectiveness Verification in GxP.
• Ability to lead root cause investigations and RCA discussions.
• Ability to engage manufacturing, engineering and quality teams cross-functionally.

Responsibilities

• Lead quality investigations for major deviations and ensure timely closure.
• Actively participate in deviation meetings and manage multiple deviations.
• Provide quality oversight for deviation documentation across shifts.
• Escalate quality, compliance, and patient-safety risks to senior management.
• Support continuous improvement and leverage learnings from deviations.

Skills

Quality-driven

Cross-functional collaboration

Root cause analysis

Investigations leadership

Documentation

Education

Doctorate degree

Master's degree + 2 years QA experience

Bachelor's degree + 4 years QA experience

Associate's degree + 8 years QA experience

High school diploma / GED + 10 years QA experience

Job description

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, i