Specialist QA

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.

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