Lead QC Microbiologist
Neogen —Lexington, KY
- Full-time
- 5 years
- Bachelor's degree
- Mentoring
6d
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University of Kentucky —Lexington, KY
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Microbiologist I
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Danimer Scientific LLC —Winchester, KY
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Piramal Enterprises —Lexington, KY
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Lead QC Microbiologist

Neogen -
Lexington, KY

Apply Now

Job Details

Full-time
6 days ago

Qualifications

Bachelor's degree

Full Job Description

Come Be Part of a Mission that Matters!

Lead QC Microbiologist

Are you an experienced microbiology professional with a passion for quality and compliance? Join our team as a Lead QC Microbiologist, where you will provide technical leadership for QC microbiology operations, environmental monitoring, investigations, and quality systems. This role supports product quality, regulatory compliance, and continuous improvement while mentoring laboratory personnel and collaborating across departments.

Key Responsibilities

Lead daily QC microbiology laboratory operations, ensuring testing is performed accurately and in compliance with GLP, cGMP, and regulatory requirements.
Perform and oversee microbiological testing of raw materials, in-process, finished product, stability, and environmental monitoring samples.
Lead investigations involving environmental monitoring excursions, OOS/OOT results, contamination events, and deviations, including root cause analysis and CAPA recommendations.
Mentor and train laboratory personnel while supporting workflow, technical development, and continuous improvement initiatives.
Support equipment qualification, calibration, validation, method transfers, troubleshooting, and laboratory maintenance activities.
Author, review, and approve SOPs, protocols, reports, investigations, change controls, and other quality documentation.
Review laboratory data for accuracy, compliance, and data integrity, supporting product disposition and quality decisions.
Analyze microbiological trends, support internal and regulatory audits, and collaborate with Quality, Manufacturing, and Regulatory teams to resolve quality issues.

Qualifications

Bachelor's degree in Microbiology, Biology, Biotechnology, or a related scientific discipline required.
Five or more years of QC microbiology experience in a pharmaceutical, biotechnology, medical device, or other regulated laboratory preferred
Demonstrated technical leadership or mentoring experience preferred.
Strong knowledge of GLP, cGMP, USP microbiological methods, FDA regulations, environmental monitoring, investigations, CAPA, and quality systems.
Excellent analytical, troubleshooting, organizational, and technical writing skills.

What We Offer

Competitive salary and comprehensive benefits package.
Opportunity to lead microbiology activities in a quality-focused laboratory.
Collaborative environment committed to scientific excellence, compliance, and continuous improvement.

If you're ready to lead by example and help ensure the highest standards of microbiological quality and compliance, we'd love to hear from you.

WHO IS NEOGEN:

From farm to fork, we offer solutions to enhance the quality, quantity and safety of the global food supply. Our animal safety solutions are used on farms, veterinary practices and manufacturers around the world to provide the best animal care possible. Whether food or pharmaceuticals, Neogen’s provides a one-stop shop for the health and safety to our animals and our customers operations.

Neogen’s culture combines stability with a deep belief in providing professional and personal growth. Our Pillars of Trust — the principles that guide our everyday decision-making, include Openness, Honesty, Credibility, Respect, and Service. It’s our belief in these characteristics that provides a consistent, happy and healthy work environment for our employees.

Apply Now

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Come Be Part of a Mission that Matters!

Key Responsibilities

Lead daily QC microbiology laboratory operations, ensuring testing is performed accurately and in compliance with GLP, cGMP, and regulatory requirements.

Perform and oversee microbiological testing of raw materials, in-process, finished product, stability, and environmental monitoring samples.

Lead investigations involving environmental monitoring excursions, OOS/OOT results, contamination events, and deviations, including root cause analysis and CAPA recommendations.

Mentor and train laboratory personnel while supporting workflow, technical development, and continuous improvement initiatives.

Support equipment qualification, calibration, validation, method transfers, troubleshooting, and laboratory maintenance activities.

Author, review, and approve SOPs, protocols, reports, investigations, change controls, and other quality documentation.

Review laboratory data for accuracy, compliance, and data integrity, supporting product disposition and quality decisions.

Analyze microbiological trends, support internal and regulatory audits, and collaborate with Quality, Manufacturing, and Regulatory teams to resolve quality issues.

Qualifications

Bachelor's degree in Microbiology, Biology, Biotechnology, or a related scientific discipline required.

Five or more years of QC microbiology experience in a pharmaceutical, biotechnology, medical device, or other regulated laboratory preferred

Demonstrated technical leadership or mentoring experience preferred.

Strong knowledge of GLP, cGMP, USP microbiological methods, FDA regulations, environmental monitoring, investigations, CAPA, and quality systems.

Excellent analytical, troubleshooting, organizational, and technical writing skills.

What We Offer

Competitive salary and comprehensive benefits package.

Opportunity to lead microbiology activities in a quality-focused laboratory.

Collaborative environment committed to scientific excellence, compliance, and continuous improvement.

If you're ready to lead by example and help ensure the highest standards of microbiological quality and compliance, we'd love to hear from you.

WHO IS NEOGEN: