Senior Specialist Contamination Control and Investigations

Senior Specialist Contamination Control and Investigations

Live What You Will Do
Let's change the world.
In this vital role, you will serve as a key member of the team responsible for advancing the site's Contamination Control Strategy while leading complex contamination-related investigations within the Amgen North Carolina Biologics Drug Substance Manufacturing plant.

• Communicate and interface between GMP manufacturing teams and stakeholder groups including Microbiology, Process Development, Facilities & Engineering, Automation, EHSS, Manufacturing, and Quality.
• Ensure contamination risks are proactively identified, assessed, controlled, and continuously improved.
• Lead high-impact investigations and support inspection readiness across the site.
• Drive improvements to contamination control programs, contamination risk assessments, and investigation processes.
• Coordinate and lead cross-functional teams through complex contamination-related investigations and complete milestones on schedule.
• Identify systemic contamination risks and drive site-wide corrective and preventive actions.
• Partner with CCS network leads, QC Microbiology, Manufacturing, Engineering, Process Development, and Quality organizations to strengthen contamination prevention programs.
• Apply advanced root cause analysis methodologies and quality risk management principles.
• Navigate ambiguity and provide a structured, science-based problem-solving approach.
• Develop metrics and tracking tools to ensure on-time closure of investigations and ongoing effectiveness of contamination control programs.
• Mentor investigators and operational personnel on contamination control principles, contamination risk management, and investigation excellence.
• Serve as a site SME for contamination control principles, contamination risk management, and contamination prevention strategies.

Basic Qualifications

• Doctorate degree & 2 years of directly related experience
• Master's degree & 4 years of directly related experience
• Bachelor's degree & 6 years of directly related experience
• Associate's degree & 10 years of directly related experience
• High school diploma/GED & 12 years of directly related experience

Preferred Qualifications

• 7+ years related work experience (microbiology, sterility assurance, manufacturing, process development, engineering, or quality assurance) in the biotechnology or pharmaceutical industry with progressively increasing responsibility.
• Strong experience with contamination control programs, contamination risk management, investigations, quality systems, and compliance.
• Microbiology studies or major a plus!
• Experience developing, implementing, or maintaining contamination control strategies and contamination risk management programs.
• Experience leading highly complex contamination-related investigations and performing contamination risk assessments to support quality and manufacturing operations.
• Knowledge of Annex 1, FDA, EMA, and global GMP requirements related to contamination control and sterility assurance.
• Experience using Veeva QMS for deviation investigations and CAPAs.
• Experience presenting during regulatory inspections and internal audits.
• Experience assessing and responding to contamination control-related audit or inspection observations and driving sustainable corrective actions.
• Demonstrated project management ability.
• Strong knowledge of environmental monitoring, utility monitoring, aseptic processing, and contamination prevention principles.
• Excellent written and verbal communication skills.
• Ability to work in a matrix environment and build strong cross-functional partnerships.
• Strong interpersonal and technical leadership skills.