Specialist QA

Amgen Inc.; Juncos (PR); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Retirement plan

Bonus program

Stock incentives

Site shutdown

Flexible work model

Job summary

Amgen Inc. in the United States seeks a Specialist QA – AML 6 to act as a key quality partner to manufacturing operations, providing oversight to ensure compliance with cGMP and Amgen quality standards.

This role supports a non-standard 12‑hour night shift and may shift with business needs; you will oversee dispositions, deviations, CAPA, change control, training, and audits, with English and Spanish bilingual communication preferred.

Qualifications

• Doctorate or equivalent degree in Life Sciences or Engineering preferred.
• Extensive QA/Manufacturing support experience required by listed levels.
• Bilingual English/Spanish is desirable for cross‑functional communication.

Responsibilities

• Execute quality disposition (approval or rejection) of bulk drug substances.
• Provide QA oversight for manufacturing, testing, storage, and distribution to ensure cGMP compliance.
• Identify, document, and manage deviations, quality events, and changes per procedures.
• Ensure production records, testing results, facilities, equipment, materials, and processes meet cGMP.

Skills

Bilingual English/Spanish

Education

Doctorate degree

Master’s degree + 2 years QA/Manufacturing

Bachelor’s degree + 4 years QA/Manufacturing

Associate’s degree + 8 years QA/Manufacturing

High school diploma + 10 years QA/Manufacturing

Tools

CDOCS

Maximo

TrackWise

LIMS

SAP

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 QA – AML 6

What you will 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).

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:

• 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 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.

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.

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.

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