Sr. Specialist, Quality

Career Category

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

Senior Specialist, Quality

What you will do

Let’s do this! Let’s change the world!

At Amgen, we are deeply committed to our mission to serve patients—and our core values, including “Ensure Quality,” are at the heart of everything we do. As part of our continued focus on innovation and excellence, we are advancing our QC Digital Optimization Initiative as part of the broader End-to-End Quality Transformation.

We are looking for a highly skilled Sr. Specialist in Quality Control (QC) with strong data analytics expertise to join our Global QC Network Team. This role offers an exciting opportunity to be a key contributor to the QC Digital Optimization Product Team, where you'll transform how QC laboratories operate by using data to enhance quality, efficiency, and compliance.

In addition to technical responsibilities, this role will serve as a Business Process Owner (BPO) for QC standardization efforts. You will drive global alignment and standardization of analytical platforms and laboratory equipment, working cross-functionally with Analytical Sciences, Digital Technology & Innovation (DTI), and other partners to influence both current operations and upstream strategies for new product introductions (NPIs).

Key Responsibilities

• Analyze and interpret complex QC data from lab instruments, manufacturing systems, and digital platforms to improve process efficiency and data-driven decision-making.

• Collaborate with QC analysts and global partners to develop data-driven strategies for quality improvement and regulatory compliance.

• Contribute to innovation in digital QC strategies, including predictive analytics, process monitoring, and big data analysis.

• Serve as Business Process Owner for global QC standardization, leading initiatives to align equipment, data systems, and methods across sites.

• Collaborate with Analytical Sciences and DTI to lead upstream efforts for analytical platform standardization, particularly in support of new product introductions (NPIs).

• Lead cross-functional alignment on equipment lifecycle and platform strategies through the Global Laboratory Asset Management (GLAM) program.

• Leverage structured and unstructured datasets from systems such as LIMS, MES, and real-time monitoring tools, ensuring data integrity and traceability.

• Design and automate QC reporting and dashboards using Power BI, Tableau, Python, or other tools for real-time visualization and insights.

• Integrate digital tools, AI, and automation to streamline QC workflows and improve laboratory performance.

• Partner with IT, data engineering, and digital transformation teams to enhance QC data infrastructure, accessibility, and analytics capability.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of Project Management, Quality and/or Operations experience OR

• Master’s degree and 4 years of Project Management, Quality and/or Operations experience OR

• Bachelor’s degree and 6 years of Project Management, Quality and/or Operations experience OR

• Associate’s degree and 10 years of Project Management, Quality and/or Operations experience OR

• High school diploma / GED and 12 years of Project Management, Quality and/or Operations experience

Preferred Qualifications:

• Bachelor’s or Master’s degree in a relevant field such as Data Science, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or a related field.

• 5+ years of exper