Specialist QA - Major Deviations

Responsibilities

• Serve as the Quality investigation lead and decision-maker for complex Major Deviations
• Provide Quality oversight to ensure pharmaceutical products comply with cGMP and applicable regulations
• Conduct thorough root cause investigations through floor presence, process observation, and personnel interviews
• Review, approve, and track cGMP documentation including Deviations, CAPAs, 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
• Escalate quality, compliance, and patient safety risks to senior management

Requirements

• Doctorate degree OR Master's with 2 years of experience OR Bachelor's with 4 years of experience OR Associate's with 8 years of experience OR High school diploma with 10 years of experience in Manufacturing Support or Quality Assurance
• Proven expertise in Quality Systems and managing Major Deviations
• Strong root cause investigation (RCA) expertise and critical thinking skills
• Proficient technical writing skills for producing inspection-ready documentation
• Experience working within a regulated GxP environment

Preferred Qualifications

• Advanced experience with CAPA and CAPA Effectiveness Verification (EV)
• Ability to perform advanced data trending and analysis to identify systemic quality signals
• Experience supporting regulatory inspections and interacting with regulatory agencies
• Ability to work flexible schedules to support manufacturing operations across different shifts

Benefits

• Comprehensive health, dental, and vision coverage
• Retirement and Savings Plan with company contributions
• Discretionary annual bonus program and stock-based long-term incentives
• Award-winning time-off plans and an annual site shutdown

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 in therapeutic areas such as Oncology, Inflammation, General Medicine, and Rare Disease.