Sr. Specialist, Quality

Amgen • Thousand Oaks, CA

264d • $128,119 - $161,488 • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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 experience in Quality Control (QC) or Manufacturing setting, with a strong focus on QC data analysis and digital optimization.
• Demonstrated leadership in digital transformation and standardization across QC systems and equipment.
• Experience leading cross-functional initiatives with Analytical Sciences and IT functions to support upstream standardization.
• Knowledge of new product introduction (NPI) processes and how they relate to laboratory readiness and platform selection.
• Deep knowledge of laboratory operations, analytical testing, quality control workflows, and regulatory requirements (e.g., GMP, GLP, FDA, ISO standards).
• Proficiency in data science and analytics tools such as Python, R, SQL, or MATLAB.
• Experience with LIMS, MES, ELN, and other digital QC systems to extract, analyze, and interpret complex datasets.
• Strong background in statistical data analysis, process monitoring, and root cause investigations in QC environments.
• Experience working with big data platforms, cloud-based analytics (AWS, Azure, GCP), and automation tools for QC data integration.
• Ability to translate complex QC datasets into actionable insights to enhance laboratory efficiency, compliance, and decision-making.
• Experience in the biotech, pharmaceutical, or medical device industries, with a strong emphasis on regulated QC environments.
• Understanding of data governance, audit trail requirements, and data security in a lab setting.

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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• 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.
• Flexible work models, including remote and hybrid work arrangements, where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree