QC Specialist

About the role

Join Amgen’s mission of serving patients. As a Quality Assurance (QA) Specialist supporting Quality Control (QC) laboratory 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. You will support the design, configuration, validation, implementation, maintenance, and continuous improvement of laboratory systems, primarily the Laboratory Information Management System (LIMS) and other laboratory computerized systems.

Responsibilities

• Serve as the Quality Control Systems Subject Matter Expert (SME) and Business Process Owner 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.
• 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 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, as well as source document revisions.
• 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.
• Author and review SOPs, Work Instructions, Forms, validation documentation, and assessments supporting QC systems.
• 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.
• Work closely with the QC network to support global harmonization of QC systems and laboratory business processes across manufacturing sites.
• 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 user experience while ensuring adherence to regulatory and data integrity requirements.

Requirements

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

Qualifications

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 lifecycle management.
• Experience authoring SOPs, sample plans, validation documentation, and Work Instructions.
• Strong technical writing, collaboration, innovation, communication, and presentation skills.
• Demonstrated ability to work effectively across global, cross-functional teams.
• Strong analytical, organizational, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment.
• Experience supporting regulatory inspections and audit readiness activities.
• Experience with SQL, reporting tools, or laboratory data analytics is preferred.
• Demonstrated commitment to continuous improvement and operational excellence.

Benefits

Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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 where possible.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.