Specialist Manufacturing – Drug Product Investigation Support

Amgen • Thousand Oaks, CA

1d • $107,545 - $145,503

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist Manufacturing - Drug Product Investigation Support What you will do Let’s do this. Let’s change the world. In this vital role, you will support the Drug Product Manufacturing Investigation Team within the Amgen Thousand Oaks Clinical Supply Organization. This position is responsible for assisting with the coordination, execution, and timely completion of minor and major manufacturing deviation investigations. The role will partner closely with major deviation investigators, manufacturing personnel, quality representatives, and subject matter experts to ensure investigations are completed in accordance with quality and regulatory requirements. This individual will play a key role in supporting deviation investigation activities, tracking progress, monitoring manufacturing-related deviations, and driving actions to completion to ensure investigation timelines are met.

Requirements

• Doctorate degree OR Master’s degree and 2 years of manufacturing experience OR Bachelor’s degree and 4 years of manufacturing experience OR Associate’s degree and 8 years of manufacturing experience OR High school diploma / GED and 10 years of manufacturing experience
• 3+ years of experience in GMP manufacturing, quality systems, investigations, or related pharmaceutical/biotechnology operations.
• Experience supporting manufacturing investigations, deviations, CAPAs, or quality systems.
• Strong project coordination and organizational skills with the ability to manage multiple priorities simultaneously.
• Experience tracking quality records and driving activities to completion within established timelines.
• Excellent written and verbal communication skills.
• Strong attention to detail and technical documentation skills.
• Ability to work effectively in a cross-functional matrix environment and build strong partnerships.
• Knowledge of GMP regulations, deviation management, investigation processes, and CAPA systems

Responsibilities

• Support the Drug Product Manufacturing Investigation Team by assisting with the execution and timely completion of manufacturing deviation investigations.
• Assist investigation owners with gathering information, attending investigation related meetings, documenting findings, and tracking investigation deliverables.
• Manage the scheduling, prioritization, and timely completion of minor manufacturing deviations while supporting the coordination of major investigations.
• Author and own minor manufacturing deviations, including documenting the event, performing the required assessment, and ensuring timely completion in accordance with quality system requirements.
• Coordinate cross-functional activities with Manufacturing, Quality Assurance, Process Engineering, Process Development, Quality Control, and other support functions.
• Assist with data collection, trend analysis, and documentation needed to support root cause analysis, product impact assessments, and CAPA development.
• Track investigation milestones, CAPAs, and action items through closure and escalate potential timeline risks when needed.
• Develop and maintain minor deviation metrics and reports to provide visibility into the status, cycle times, and compliance performance.
• Support continuous improvement initiatives focused on investigation processes, compliance, and operational efficiency.
• Maintain accurate and compliant documentation within electronic quality management systems.
• Support the investigation team with inspection and audit readiness activities, including investigation support and documentation.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed