QC Specialist

About this role

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

QC Specialist

What you will do Let’s do this. Let’s change the world. In this vital role you will serve as the Quality Assurance (QA) Specialist supporting Quality Control (QC) laboratory systems, with primary responsibility for the Laboratory Information Management System (LIMS) and other laboratory computerized systems. You will ensure QC systems remain compliant with GMP regulations, Data Integrity requirements, Computer System Validation (CSV) expectations, and Amgen's Quality Management System while supporting the design, configuration, validation, implementation, maintenance, and continuous improvement of laboratory systems as applicable.

• Serve as the Quality Control Systems Subject Matter Expert (SME) and Business Process Owner as applicable for Sample Manager LIMS and associated laboratory computerized systems.

• Support the lifecycle management of laboratory systems, including design, configuration, implementation, validation, maintenance, upgrades, and retirement.

• Maintain laboratory computerized systems in compliance with GMP, 21 CFR Part 11 and Amgen Quality Management System requirements.

• Configure, maintain and approve LIMS templates related to sample plans and specifications.  

• Support implementation of new functionality and deployment of QC systems in alignment with Amgen network initiatives as applicable.

• Support laboratory data retrieval through query execution and reporting tools.

• Provide technical support to QC laboratories to ensure laboratory operations meet regulatory requirements and business needs.

• Provide technical and critical systems support as applicable across multiple shifts when required.

• Support laboratory processes through the LIMS system associated with raw materials, utilities, in-process testing, stability, environmental monitoring, cleaning validation, and finished product testing.

• Serve as a SME for revisions and LIMS templating related to sample plans, laboratory metrics and trending program queries.

• Support LIMS templating related to new product introductions and product re-introductions in addition to source document revisions on a routine basis.

• Assist with planning and coordination of laboratory system enhancements and process improvements.

• Ensure laboratory systems remain inspection ready through proactive monitoring, periodic reviews and change management.

• Support deviations and investigations from a systems perspective as applicable.

• Author and review SOPs, Work Instructions, Forms, validation documentation and assessments supporting QC systems as applicable.

• Support internal audits and represent QC Systems during regulatory inspections.

• Partner with cross-functional teams including Manufacturing, Process Development, Engineering, Information Systems, Supply Chain, and Global Quality.

• Provide technical guidance and mentoring to laboratory users and QC personnel on laboratory systems and best practices.

• Develop and deliver training materials related to QC systems and computerized system processes as applicable.

• Work closely with the QC network to support global harmonization of QC systems and laboratory business processes across manufacturing sites and support implementation at the site level.

• Utilize laboratory metrics and data analytics to identify trends and drive continuous improvement.

• Evaluate and implement innovative technologies that enhance compliance, reduce manual effort, and improve the user experience while ensuring adherence to regulatory and data integrity requirements.

What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of quality, quality systems, or quality control experience OR Bachelor’s degree and 4 years of quality, quality systems, or quality control experience OR Associate’s degree and 8 years of quality, quality systems, or quality control experience OR High school diploma / GED and 10 years of quality, quality systems, or quality control experience

Preferred Qualifications: • 5+ years of experience in pharmaceutical or biotechnology Quality Control, Quality Assurance, or Quality Systems.

• Experience supporting Laboratory Information Management Systems (LIMS), preferably Sample Manager LIMS.

• Strong understanding of laboratory operations, analytical testing, sample management, and QC workflows.

• Experience supporting computerized laboratory systems including Empower, Electronic Laboratory Notebook (ELN/LMES), Veeva, Kneat, ALM, or similar platforms.

• Demonstrated knowledge of GMP regulations, 21 CFR Part 11, Data Integrity principles, and regulatory inspection expectations.

• Experience supporting system implementation and system

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