Specialist QA

Amgen SA; Juncos (PR); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision coverage

Life & disability insurance

Bonus program

Stock-based incentives

Time-off plans & site shutdown

Job summary

Amgen seeks a Specialist QA to lead Quality Risk Management and Change Control activities across GxP operations. You will drive risk assessment processes and partner with cross‑functional teams to ensure patient safety and product quality, while maintaining governance and inspection readiness.

The role requires strong analytical, communication, and technical writing skills, with experience applying QRM tools and regulatory standards in a biopharmaceutical setting.

Qualifications

• Doctorate degree required or Master’s with 2+ years QA/Manufacturing experience or Bachelor’s with 4+ years in QA/Manufacturing or Associate’s with 8+ years QA/Manufacturing or high school diploma with 10+ years QA/Manufacturing experience.

Responsibilities

• Lead and support Quality Risk Management (QRM) activities to protect patient safety and product quality.
• Manage risk assessments using FMEA, HACCP, and PrHA.
• Collaborate with cross-functional teams to embed QRM in deviations, CAPA, investigations, and change controls.
• Maintain QRM governance, documentation, procedures, and metrics.
• Analyze risk data to support risk-based decision making.
• Oversee GxP change control lifecycle from initiation to closure.
• Oversee qualification, validation, documentation, and regulatory assessments for implementation.
• Drive continuous improvement in QRM and Change Control using data trends and lessons learned.
• Support inspection readiness for QRM and Change Control with retrievable evidence and audit follow‑up actions.

Skills

Analytical

Communication

Technical writing

Cross-functional

Problem solving

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

CCMS

TrackWise

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 QA

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead and support Quality Risk Management (QRM) and Change Control Quality System activities that enable proactive, science-based decision making to protect patient safety, product quality, regulatory compliance, and business continuity across GxP-regulated operations.

• Facilitate and support risk assessments using established methodologies such as FMEA, HACCP, and Preliminary Hazard Analysis (PrHA).
• Evaluate and document risks impacting patient safety, product quality, compliance, and supply continuity.
• Partner with cross‑functional teams to integrate QRM principles into deviations, CAPAs, investigations, and change controls.
• Maintain QRM governance processes, risk management documentation, procedures, training programs, and performance metrics.
• Analyze risk data and trends to support risk‑based decision making.
• Manage the GxP change control lifecycle from initiation through timely closure, including classification, risk assessment, approvals, implementation, and effectiveness verification.
• Oversee qualification, validation, documentation, training, regulatory assessments, and evidence required for implementation and closure.
• Drive continuous improvement across QRM and Change Control using performance trends, lessons learned, and human‑performance principles to reduce recurrence and strengthen controls.
• Support inspection readiness for QRM and Change Control by maintaining retrievable evidence, presenting program governance and performance, and coordinating audit and regulatory inspection follow‑up actions.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Specialist Quality Assurance professional we seek is an individual contributor with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 2 years of Quality Assurance or Manufacturing support experience

OR

Bachelor’s degree and 4 years of Quality Assurance or Manufacturing support experience

OR

Associate’s degree and 8 years of Quality Assurance or Manufacturing support experience

OR

High school diploma / GED and 10 years of Quality Assurance or Manufacturing support experience

Preferred Qualifications:

• Experience implementing Quality Risk Management programs within a GxP-regulated biopharmaceutical, pharmaceutical, medical device, or manufacturing environment.
• Strong knowledge of cGMP requirements and risk management standards including ICH Q9, ICH Q10, and ISO 14971.
• Demonstrated experience facilitating and documenting risk assessments using tools such as FMEA, HACCP, PrHA, and other risk‑based decision‑making methodologies.
• Working knowledge of Quality Systems and their integration with deviations, CAPA, investigations, change control, management review, and continuous improvement processes.
• Strong analytical, communication, and technical writing skills, with the ability to influence cross‑functional stakeholders and support audit and inspection readiness activities.
• Demonstrated experience leading the GxP change control lifecycle, including change definition and classification, risk and impact assessment, implementation planning, approval, effectiveness verification, and closure.
• Proficiency using an electronic Quality Management System such as CCMS, TrackWise, or an equivalent platform to manage workflows, audit trails, reporting, and complete, accurate, inspection‑ready records in accordance with data‑integrity principles.

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.

In any materials you submit, you may redact or remove age‑identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.