New · posted Oct 25
Amgen · Biotechnology
Specialist QA
- Juncos, PR
- On-site
- Full-time
- Associate & Specialist
What you need
Basic Qualifications
Doctorate degree
Master’s degree and 2 years of Quality Assurance or Manufacturing support experience
Bachelor’s degree and 4 years of Quality Assurance or Manufacturing support experience
Associate’s degree and 8 years of Quality Assurance or Manufacturing support experience
High school diploma / GED and 10 years of Quality Assurance or Manufacturing support experience
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.
Preferred Qualificationsnice to have
- 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'll 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.
Pay and benefits
Amgen didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
What you can expect of us
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.
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:
Where you'll work
Juncos, PROn-siteOpen in Maps (opens in a new tab)
More jobs in Juncos, PRWorking conditions
Career Category
Quality
careers.amgen.com
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.
From the posting
About Amgen
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.
Equal opportunity, accessibility and legal noticesAmgen's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 28, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US181 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $59,000 | $81,000 | $95,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 961 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Amgen's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk13
- GMP and compliance9
- Documentation and SOPs6
- Collaboration and leadership5
- Lab testing and methods3
- Investigations and CAPA2
- Validation and qualification1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
Amgen on Regulatory Jobs
- 34
- Open roles
- 31
- Distinct roles
- 6
- Locations
By discipline
- Quality25 74%
- Regulatory7 21%
- Compliance & Safety2 6%
By level
- Manager14 41%
- Senior & Principal11 32%
- Associate & Specialist6 18%
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Specialist QA at Amgen
Applications close October 30.