Specialist QC

About the Role

Join Amgen’s mission to serve patients and make a lasting impact on their lives. As a Specialist QC, you’ll support analytical investigations within the QC Technical Services team, ensuring compliance with GMP requirements and internal quality standards.

Responsibilities

• Analytical Investigation Ownership: Lead investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, and unexpected analytical results. Perform root cause analysis and develop corrective and preventive actions (CAPAs).
• Quality Systems & Risk Assessment: Own and support deviations, CAPAs, and effectiveness verifications. Review and approve equipment-related change controls. Partner with Quality Assurance for risk-based, inspection-ready outcomes.
• Cross-Functional Collaboration: Work with Quality Control laboratories, Manufacturing, Process Development, Quality Assurance, Supply Chain, and other teams to resolve complex quality events. Facilitate communication and engage subject matter experts as needed.
• Inspection Readiness: Support internal and external audits by communicating investigation findings, root cause, and CAPA effectiveness. Maintain complete and accurate documentation.

Qualifications

• Basic Qualifications:
  • High school diploma/GED and 10 years of directly related experience
  • Associate's degree and 8 years of directly related experience
  • Bachelor's degree and 4 years of directly related experience
  • Master's degree and 2 years of directly related experience
  • Doctorate degree
• Preferred Qualifications:
  • Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or another Life Science discipline.
  • 5–8+ years of Quality Control or Quality Assurance experience in biotechnology or pharmaceuticals.
  • Demonstrated experience leading complex laboratory investigations, including OOS, OOT, and laboratory deviations.
  • Strong knowledge of GMP regulations, laboratory quality systems, and deviation management processes.
  • Experience with root cause analysis and structured problem-solving methodologies.
  • Understanding of analytical techniques, instrumentation, and data integrity principles.
  • Experience authoring and managing deviations, CAPAs, change controls, and effectiveness verifications.
  • Strong communication skills and ability to influence cross-functional teams.
  • Experience supporting regulatory inspections and responding to auditor inquiries.
  • Preferred: Experience with digital tools, data analytics, or AI-enabled technologies to improve laboratory processes.

Benefits

Amgen offers a Total Rewards Plan, including:

• Comprehensive employee benefits package with retirement and savings plans, medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program or sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans and 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 relevant skills, experience, and qualifications.