Specialist Quality Assurance – Drug Product Minor Deviations

Responsibilities

• Serve as the Quality investigation lead and decision-maker for complex deviations, ensuring timely closure and high-quality documentation.
• Provide Quality oversight through floor presence, process observation, and personnel interviews to ensure thorough investigation of deviations.
• Review, approve, and track cGMP documentation, including deviations, procedure updates, and associated records.
• Collaborate cross-functionally with Manufacturing, Engineering, Validation, and Quality teams to ensure accurate information for deviation resolution.
• Escalate quality, compliance, and patient safety risks to senior management as appropriate.
• Defend deviations during internal audits and regulatory inspections.
• Support continuous improvement initiatives by leveraging deviation learnings to prevent recurrence.

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 High school + 10 years QA experience.
• Proven experience in Quality Systems, specifically regarding Deviations and CAPA.
• Strong knowledge of GxP environments and cGMP standards.
• Expertise in root cause investigation and technical writing.
• Ability to work on-site and maintain flexibility for various shifts or operational needs.

Preferred Qualifications

• Academic degree in Life Science or Engineering.
• Advanced experience in CAPA Effectiveness Verification (EV) within a regulated environment.
• Proven experience supporting regulatory inspections and interacting with regulatory agencies.
• Ability to perform advanced data trending and analysis to identify systemic quality signals.
• Proficiency in leveraging digital tools and automation to improve investigation effectiveness.

Benefits

• Comprehensive health and welfare plans, including 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 serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases, focusing on delivering innovative medicines that help people live longer, fuller, and happier lives.