New · posted Oct 13
Amgen · Biotechnology
Specialist QA
- Juncos, PR
- On-site
- Full-time
- Associate & Specialist
Closes Nov 12, 2026 · 30 days left
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
- Educational background in Life Sciences and/or Engineering.
- Expertise in Quality Systems, including Deviations (Non‑conformities), CAPA, and Change Control.
- Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
- Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting‑level technical proficiency.
- Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
- Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
- Experience providing Quality support for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products.
- Strong organizational skills, with the ability to drive assignments through successful completion.
- Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues.
- Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels.
What you'll do
Let’s do this. Let’s change the world! In this vital role, you will serve as a key Quality partner to manufacturing operations, providing oversight and guidance to ensure compliance with cGMP requirements, regulatory expectations, and Amgen quality standards. This position currently supports a non-standard 12-hour night shift; however, work schedules may be adjusted in the future based on business needs.
- Execute Quality disposition (approval or rejection) of bulk drug substances.
- Provide Quality oversight for clinical and commercial drug substance operations to ensure manufacturing, testing, storage, and distribution activities are conducted in compliance with cGMP, cGLP, and other applicable regulatory requirements.
- Ensure deviations, quality events, and proposed changes that may impact product quality are appropriately identified, assessed, documented, and managed in accordance with established procedures.
- Ensure production records, testing results, facilities, equipment, materials, processes, and procedures comply with cGMP requirements and are maintained in a complete, accurate, and inspection-ready state.
- Collaborate cross-functionally to ensure Quality Management System (QMS) processes are effectively executed and support compliant operations.
- Champion continuous improvement initiatives, programs, and projects to enhance operational efficiency, quality, and compliance.
- Complete all required training and maintain training compliance to support effective execution of assigned responsibilities.
- Support internal and external audits and regulatory inspections, serving as a Quality Unit representative when required.
- Escalate quality, compliance, supply, and safety risks to senior management, as appropriate.
- Provide Quality support and oversight for New Product Introductions (NPI).
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 13, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US103 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $72,000 | $84,000 | $100,750 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 642 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 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance10
- Documentation and SOPs4
- Quality systems and risk4
- Collaboration and leadership4
- Lab testing and methods3
- Validation and qualification3
- Investigations and CAPA2
- Data and digital systems2
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.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Amgen on Regulatory Jobs
- 36
- Open roles
- 32
- Distinct roles
- 5
- Locations
By discipline
- Quality26 72%
- Regulatory8 22%
- Compliance & Safety2 6%
By level
- Manager15 42%
- Associate & Specialist10 28%
- Senior & Principal8 22%
More roles at Amgen
- View role
R&D Supplier Quality Sr Manager
Remote, USManagerBiotechnology$132K–$179K
- View role
Principal Product Quality Leader (Synthetics)
Thousand Oaks, CA +1 moreSenior & PrincipalBiotechnology$139K–$188K
- View role
Product Quality Director - Hybrid Modalities
Thousand Oaks, CA +1 more · HybridDirectorBiotechnology$176K–$239K
- View role
R&D Supplier Quality Manager
Remote, USManagerBiotechnology$104K–$141K
Similar Quality Assurance roles elsewhere
- View role
2027 Spring Intern - PTQ Quality Processes
GenentechSouth San Francisco, CAAssociate & SpecialistBiotechnology$52K–$108K
- View role
QA Specialist II
Gilead SciencesEl Segundo, CAAssociate & SpecialistBiotechnology$93K–$120K
- View role
QA Auditor I
Thermo Fisher ScientificRichmond, VAAssociate & SpecialistBiotechnologySalary not listed
- View role
QA Documentation Specialist I
Gilead SciencesFrederick, MDAssociate & SpecialistBiotechnology$80K–$104K
Specialist QA at Amgen
Applications close November 12.