Specialist QA

Regulatory Jobs; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Retirement plan

Health insurance

Stock options

Flexible work model

Job summary

Amgen seeks a Specialist QA – AML 6 to act as a key Quality partner for manufacturing operations. You will ensure cGMP compliance, oversee drug substance operations, and manage deviations and quality events.

The role may involve a non-standard 12-hour night shift with potential schedule adjustments. The ideal candidate will have a Doctorate or equivalent, with extensive QA/manufacturing experience, deep knowledge of QA systems, and bilingual English/Spanish communication skills.

Qualifications

• PhD or equivalent required/4+ years QA or manufacturing support experience for alternate degrees

Responsibilities

• Serve as Quality partner to manufacturing operations to ensure cGMP compliance
• Provide oversight for clinical and commercial drug substance operations
• Manage deviations, quality events, and changes per procedures
• Ensure production records, testing results, and facilities comply with cGMP
• Collaborate to execute QMS processes and compliance
• Drive continuous improvement initiatives for quality and efficiency
• Complete required training and maintain compliance
• Support internal and external audits and regulatory inspections
• Escalate risks to senior management
• Provide QA support for New Product Introductions (NPI)

Skills

Bilingual English/Spanish

Leadership

Strong communication

Organizational skills

Education

Doctorate degree

Master’s degree + 2 years QA experience

Bachelor’s degree + 4 years QA

Associate’s degree + 8 years QA

High school diploma + 10 years QA

Tools

CDOCS

Maximo

TrackWise

LIMS

MES (electronic batch records)

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

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.