Specialist QA

Amgen; Juncos (PR); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision coverage

Performance bonus

Flexible work options

Annual site shutdown

Job summary

Amgen in Puerto Rico seeks a Specialist QA – AML 6 to execute quality dispositions of bulk drug substances and provide QA oversight for drug substance operations, ensuring cGMP/cGLP compliance and inspection readiness. The role collaborates across functions to maintain QMS processes, drive continuous improvement, and support audits and regulatory inspections.

The ideal candidate will have advanced degrees with QA/manufacturing experience, strong communication skills, and bilingual proficiency in

Qualifications

• Advanced degree in life sciences or engineering, with QA/manufacturing exposure.
• Experience with deviations, CAPA, and change control in cGxP environments.
• Strong knowledge of manufacturing and distribution processes and regulatory expectations.

Responsibilities

• Execute quality disposition (approval or rejection) of bulk drug substances.
• Provide QA oversight for clinical and commercial drug substance operations per cGMP/cGLP.
• Manage deviations, quality events, and changes per procedures.
• Ensure production records and testing results are inspection-ready.
• Collaborate to execute QMS processes and drive continuous improvement.
• Support audits and regulatory inspections as a QA representative.
• Escalate risks to senior management and support NPI quality needs.

Skills

Quality mindset

Cross-functional collaboration

Communication skills

Bilingual English/Spanish

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

CDOCS

Maximo

TrackWise

LIMS

MES

SAP

CSV validation

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

• 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 independent and effectively across all organizational levels.

What you can expect of us

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