Senior Associate Quality Control

Overview

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 biotech in our fight against the world’s toughest diseases. With a focus on 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. amgen’s FleX Batch facility will combine latest single-use technologies with traditional stainless steel equipment to allow maximum flexibility in operations. The facility will feature best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and will integrate sustainability innovations to reduce carbon and waste as part of Amgen’s plan to be carbon-neutral by 2027.

In this vital role you will play a key role in the Quality Control team as the site’s Business Process Owner (BPO) for laboratory notebook and consumables management computerized systems. Reporting directly to the Manager of Quality Control Support, you will serve as a subject matter expert for QC on the implementation, usage, and governance of laboratory-based computerized systems used for documentation of analytical testing and consumables management.

You will lead and direct other QC and cross-functional staff as an informed Subject Matter Expert (SME). The SME will apply sophisticated thinking to ensure quality and compliance with GMP regulations for QC digital operations. Because this role is tightly integrated with manufacturing operations, occasional extended hours, shift work, or weekend support for troubleshooting may be required.

Working under minimal supervision, the successful candidate will contribute to both startup and daily operations of the QC organization by:

• Provide support and guidance to laboratory users of Laboratory Notebook and Consumables Management computerized systems throughout the system lifecycle.
• Collaborate closely with QC teams to develop a strong solid understanding of laboratory processes and procedures.
• Lead effort to capture data and requirements from analytical testing groups to interface with corporate teams in support of the development, qualification, and implementation of QC master data.
• Author, review, and revise system related controlled documentation including SOPs, Work Instructions, trend reports, training materials, and validation documentation.
• Train laboratory users on system usage ensuring training records are compliant prior to requesting system access.
• Support deviation and CAPA records to maintain system compliance and quality standards.
• Contribute to the inspection readiness program and represent QC systems during regulatory audits; may directly interact with regulatory agencies during inspections.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for equipment implementation. Support Lean Transformation and Operational Excellence initiatives.
• Ensure that all activities and related documentation comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong great teammate with these qualifications.

• High school diploma / GED and 4 years of Quality, Analytical Testing, or GxP Computerized System validation experience OR
• Associates degree and 2 years of Quality, Analytical Testing, or GxP…