Specialist Quality Assurance – Drug Substance Deviations

Responsibilities

• Serve as a Quality leader responsible for the timely triage, investigation, and resolution of drug substance deviations to ensure cGMP compliance.
• Provide Quality oversight to ensure pharmaceutical products are manufactured, tested, and distributed in compliance with applicable regulations.
• Critically review and challenge deviation classifications and initial write-ups to ensure accurate reflection of events.
• Conduct thorough root cause investigations (RCA) through floor presence, process observation, and personnel interviews.
• Review, approve, and track cGMP documentation, including Deviations, CAPAs, CAPA Effectiveness Verification (EV), and Change Controls.
• Collaborate cross-functionally with Manufacturing, Engineering, and Validation teams to implement sustainable CAPAs.
• Defend investigation strategies and root cause conclusions during internal audits and regulatory inspections.

Requirements

• Doctorate degree OR Master's + 2 years QA experience OR Bachelor's + 4 years QA experience OR Associate's + 8 years QA experience OR HS/GED + 10 years QA experience.
• Proven experience in Quality Systems, specifically managing Deviations, CAPA, and CAPA Effectiveness Verification (EV).
• Strong knowledge of GxP environments and cGMP standards.
• Expertise in root cause investigation methodologies.
• Excellent technical writing skills for producing inspection-ready documentation.

Preferred Qualifications

• Academic degree in Life Sciences or Engineering.
• Experience supporting drug substance operations in a GMP-regulated environment.
• Proven ability to lead complex investigations and facilitate cross-functional RCA discussions.
• Experience supporting regulatory inspections and interacting with regulatory agencies.
• Ability to perform advanced data trending and analysis to identify systemic quality risks.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Retirement and Savings Plan with company contributions.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.

About the Company

Amgen is a leading biotechnology company dedicated to discovering, developing, and manufacturing innovative human therapeutics. Since 1980, Amgen has focused on serving patients living with serious illnesses across oncology, inflammation, general medicine, and rare diseases.