Specialist QA

Amgen; Puerto Rico; On-site; USD 110,000 - 150,000; Full time

Job summary

Amgen seeks a Specialist QA to serve as a key quality partner to manufacturing operations, ensuring cGMP compliance and adherence to regulatory expectations. The role supports non-standard 12‑hour night shifts with potential schedule adjustments as needed.

Responsibilities include disposition of bulk drug substances, QA oversight of manufacturing, testing, storage, and distribution, and continuous improvement projects to enhance efficiency and compliance.

Qualifications

• Doctorate or equivalent in life sciences or engineering.
• Master's degree with 2+ years QA/manufacturing support experience or Bachelor's with 4+ years QA/manufacturing support experience.
• Associate's with 8+ years QA/manufacturing support, or High school/GED with 10+ years QA/manufacturing support.

Responsibilities

• Execute Quality disposition (approval or rejection) of bulk drug substances.
• Provide Quality oversight for clinical and commercial drug substance operations to ensure compliance with cGMP, cGLP, and other regulatory requirements.
• Ensure deviations, quality events, and changes are identified, assessed, documented, and managed.
• Ensure production records, testing results, facilities, equipment, materials, processes, and procedures meet cGMP and inspection readiness.
• Collaborate to ensure QMS processes are effectively executed and compliant operations.
• Champion continuous improvement initiatives to enhance quality and compliance.
• Complete required training and maintain training compliance.
• Support internal and external audits and regulatory inspections as a Quality Unit representative.

Skills

Quality Assurance

Regulatory knowledge

Communication skills

Bilingual English/Spanish

Cross-functional collaboration

Documentation & records

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Tools

CDOCS

Maximo

TrackWise

LIMS

MES/electronic batch record systems

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
• 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

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 team