Supervisor, Quality Control – Microbiology

Jobtailor

North Carolina

On-site

USD 95,000 - 145,000

Full time

4 days ago

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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

Lead, supervise, coach, and develop 6–12 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

Requirements

Bachelor’s degree in Life Science or Biology
At least 4 years of experience in a cGMP environment
BioWork certificate preferred
Experience with environmental monitoring in ISO/Classified spaces and utilities testing
Experience with sterility testing, endotoxin/LAL, bioburden/microbial limits, growth promotion, microbial identification, AET/MVT, and data trending
Experience with deviation/OOS/OOT investigations, root cause analysis, and CAPA management
Familiarity with LIMS/ELN and TrackWise or similar eQMS
Proficiency with MS Office/Teams
Knowledge of cGMP, data integrity (ALCOA+), ICH Q7/Q9/Q10, USP/EP/JP, and EU Annex 1 (2022)
Strong leadership, prioritization, communication, and cross-functional collaboration skills
Ability to operate in a fast-paced, shifting-priority environment and make sound, risk-based decisions
Ability to work in an environment that may necessitate respiratory protection
Ability to discern audible cues
Ability to perform tasks with 20/20 corrected vision and distinguish color
Ability to ascend or descend ladders, scaffolding, and ramps
Ability to stand and sit for prolonged periods of time (240 minutes)
Ability to perform repetitive motions using wrists, hands, and/or fingers
Ability to move objects up to 33 lbs
Ability to bend, push, pull, reach, and use twisting motions
Ability to work in warm/cold environments ranging from 0–100°F

Core Competencies

Demonstrates expertise in leading and developing QC Microbiology teams while ensuring compliance with regulatory standards and maintaining data integrity. Proficient in environmental monitoring, microbiological methods, and CAPA management within a cGMP environment.

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