QC Microbiology Lead - Elevate Compliance & Throughput

Jobtailor; North Carolina; On-site; USD 95,000 - 145,000; Full time

Job summary

Jobtailor is seeking a senior QC Microbiology leader in the United States (North Carolina) to inspire and develop a team of 6–12 analysts. You’ll drive environmental monitoring programs, ensure regulatory compliance, and manage data integrity across LIMS/ELN platforms while coordinating with Manufacturing, Validation, and Facilities.

The role emphasizes CAPA management, risk assessment, and continuous improvement.

Qualifications

• Bachelor’s degree in Life Science or Biology.
• 4+ years of experience in a cGMP environment.
• BioWork Certificate preferred.

Responsibilities

• Lead, supervise, coach, and develop QC Microbiology analysts.
• Manage scheduling, training, performance feedback, and career development.
• Maintain team qualification matrices and ensure training is current and effective.
• Oversee environmental monitoring and utility programs, including viable/non-viable monitoring, compressed gases, WFI/PW, and clean steam.
• Ensure timely and compliant execution of compendial and in-house microbiological methods.
• Review and approve data, test records, LIMS entries, and certificates of analysis.
• Ensure ALCOA+ data integrity.
• Manage sample logistics, inventory, and equipment readiness, including calibration and preventive maintenance.
• Lead or approve QC Micro deviations, OOS/OOT, environmental monitoring excursions, and product impact assessments.
• Author and implement CAPAs and change controls.
• Contribute to risk assessments, trend reports, stability/annual product review inputs, and APR/PQR.
• Maintain and improve SOPs, methods, and validation/qualification documents.
• Partner with Manufacturing, Validation, and Facilities on contamination control, cleanroom behavior, gowning, cleaning/disinfection, and aseptic interventions.
• Support media fills, aseptic qualifications, and Annex 1 compliance initiatives.
• Drive throughput, right-first-time, and turnaround-time improvements using Lean/Six Sigma tools.
• Support or lead rapid microbiology method implementation, LIMS/ELN upgrades, and new equipment qualifications.
• Ensure compliance with FDA/EMA/PMDA/MHRA, USP/EP/JP, ICH, and EU Annex 1 requirements.
• Host or support internal and external audits and maintain an inspection-ready laboratory.

Skills

Leadership

Environmental Monitoring

CAPA Management

Data Integrity

Education

Bachelor’s degree in Life Science or Biology

Tools

LIMS

ELN

TrackWise

MS Office

Teams

Job description

Jobtailor is seeking a senior QC Microbiology leader in the United States (North Carolina) to inspire and develop a team of 6–12 analysts. You’ll drive environmental monitoring programs, ensure regulatory compliance, and manage data integrity across LIMS/ELN platforms while coordinating with Manufacturing, Validation, and Facilities.

The role emphasizes CAPA management, risk assessment, and continuous improvement.