Senior QC Microbiologist - Aseptic & Sterility Leader

Guerbet; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Guerbet seeks an experienced QC Senior Microbiologist to lead microbiological quality systems in an aseptic pharmaceutical facility. You will oversee sterility programs, EM data, CAPAs, and investigations to ensure cGMP compliance and data integrity.

You will train junior staff, guide contamination control strategies, and contribute to continuous improvement in environmental monitoring and product quality.

Qualifications

• Bachelor's degree in Microbiology or related life science required.
• Minimum 5–8 years microbiology in pharma/biotech/aseptic manufacturing environment.
• Experience supporting aseptic processing/terminal sterilization cleanroom operations.

Responsibilities

• Provide microbiological oversight of aseptic manufacturing processes, including cleanroom operations and aseptic filling.
• Support sterility assurance programs and regulatory expectations.
• Review environmental monitoring data and trends for classified areas (ISO 5–8).
• Lead environmental monitoring programs, routine sampling, excursion response, and data trending.
• Perform root cause analysis and implement CAPAs to prevent recurrence.
• Oversee method validation, verification, and suitability activities.

Skills

Microbiology

Aseptic processing

Environmental Monitoring

CAPA

Regulatory compliance

cGMP

Education

Bachelor's degree in Microbiology

Master's degree (preferred)

Job description

Guerbet seeks an experienced QC Senior Microbiologist to lead microbiological quality systems in an aseptic pharmaceutical facility. You will oversee sterility programs, EM data, CAPAs, and investigations to ensure cGMP compliance and data integrity.

You will train junior staff, guide contamination control strategies, and contribute to continuous improvement in environmental monitoring and product quality.