Senior QC Microbiologist - Aseptic & Sterility Lead

Guerbet; Raleigh (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Guerbet seeks a QC Senior Microbiologist to lead microbiological quality systems in an aseptic pharmaceutical manufacturing facility. You will oversee sterile processes, environmental monitoring, trend analysis, investigations, and CAPA execution to ensure cGMP compliance and data integrity.

You will provide technical guidance to junior microbiologists and manufacturing staff, collaborate with QA, and support contamination control strategies while maintaining robust documentation and regulatory

Qualifications

• Bachelor’s degree in Microbiology, Biology, or related life science.
• Minimum of 5–8 years of microbiology experience in pharma/biotech aseptic manufacturing.
• Demonstrated experience supporting aseptic processing/terminal sterilization cleanroom operations.

Responsibilities

• Provide microbiological oversight of aseptic manufacturing processes, including cleanroom operations.
• Support sterility assurance programs, ensuring regulatory expectations are met.
• Review and approve environmental monitoring data and trends for classified areas (ISO 5-8).
• Ensure viable and non-viable monitoring strategies are appropriate for aseptic conditions.
• Lead environmental monitoring programs, including routine sampling and trend analysis.
• Perform root cause analysis and implement CAPAs for investigations.
• Oversee method validation, verification, and suitability activities.
• Serve as SME for microbiological and aseptic processing topics.

Skills

Microbiology

Environmental Monitoring

CAPA investigations

Data interpretation

GMP compliance

Education

Bachelor’s degree in Microbiology

Master’s degree in Microbiology

Job description

Guerbet seeks a QC Senior Microbiologist to lead microbiological quality systems in an aseptic pharmaceutical manufacturing facility. You will oversee sterile processes, environmental monitoring, trend analysis, investigations, and CAPA execution to ensure cGMP compliance and data integrity.

You will provide technical guidance to junior microbiologists and manufacturing staff, collaborate with QA, and support contamination control strategies while maintaining robust documentation and regulatory