Specialist Quality Assurance - Major Deviations

Amgen; Juncos (PR); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Stock‑based long‑term incentives

Discretionary annual bonus

Flexible work models where possible

Job summary

Amgen is seeking a Specialist Quality Assurance – Major Deviations to lead investigations of critical deviations, safeguard product quality and patient safety, and collaborate across Manufacturing, Engineering, Validation, and Quality teams in a dynamic drug product environment. You will oversee deviation documentation, CAPA, and regulatory readiness, using AI tools where appropriate.

The role requires advanced QA experience, strong writing skills, and a proven ability to drive timely, compliant

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
• 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.

Responsibilities

• 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.

Skills

Quality leadership

Root cause investigations

Cross-functional collaboration

Regulatory inspections experience

Technical writing

Digital tools / AI-enabled tools

GxP / cGMP knowledge

Education

Doctorate or Master’s + QA experience

Bachelor’s + QA experience

Associate + QA experience

High school diploma + 10 years QA

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, 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.

Benefits and compensation

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.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation .

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen