Contamination Control Investigator - Remote-Eligible

Amgen SA; Holly Springs (NC); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work models

Retirement and savings plan

Job summary

Amgen North Carolina Biologics Drug Substance Manufacturing plant in Holly Springs seeks a Senior Specialist in Contamination Control and Investigations. You will lead complex contamination-related investigations, interfacing with Microbiology, Process Development, Facilities & Engineering, Automation, EHSS, Manufacturing and Quality to proactively identify and control contamination risks.

You will provide technical leadership for audits and inspections, develop risk-based remediation

Qualifications

• Doctorate with 2+ years related experience; or Master’s with 4+ years; Bachelor’s with 6+ years; Associate’s with 10+ years; HS with 12+ years.
• Strong contamination control, microbiology, sterility, investigations and quality systems experience.
• Experience with regulatory inspections and CAPA processes is preferred.

Responsibilities

• Manage contamination-related deviation investigations including microbial excursions and environmental monitoring events.
• Represent the site in contamination control networks and drive standards and best practices.
• Provide technical leadership for audit/inspection responses and corrective actions.
• Develop and maintain the site's contamination control strategy and risk assessments.
• Lead cross-functional teams through investigations and ensure on-time milestones.
• Mentor investigators on contamination control principles and risk management.
• Present strategies and risk assessments to inspectors, auditors, and site leadership.
• Ensure ongoing effectiveness of contamination control programs and action tracking.

Skills

Contamination control

Microbiology

Sterility assurance

Investigations

Quality systems

Regulatory inspections

Project management

Cross-functional collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

Tools

Veeva QMS

Job description

Amgen North Carolina Biologics Drug Substance Manufacturing plant in Holly Springs seeks a Senior Specialist in Contamination Control and Investigations. You will lead complex contamination-related investigations, interfacing with Microbiology, Process Development, Facilities & Engineering, Automation, EHSS, Manufacturing and Quality to proactively identify and control contamination risks.

You will provide technical leadership for audits and inspections, develop risk-based remediation