Lead QC Microbiologist

Reposted Yesterday
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Lexington, KY, USA
In-Office
Mid level
Biotech • Pharmaceutical
The Role
Perform routine QC microbiological testing and environmental monitoring under GLP/cGMP. Administer and document quality systems, investigate deviations, support method/equipment qualification, write and revise lab SOPs and reports, participate in audits, CAPA, batch review, and data trending to ensure product quality and regulatory compliance.
Summary Generated by Built In
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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.

Skills Required

  • Bachelor's degree in Microbiology, Biology, Biotechnology, or related scientific discipline (or equivalent laboratory experience).
  • Experience in a QC microbiology, pharmaceutical, biotechnology, medical device, or similarly regulated laboratory environment.
  • Working knowledge of GLP, cGMP, laboratory documentation standards, deviation investigations, change control, and quality management systems.
  • Ability to perform microbiological testing, environmental monitoring, data review, and accurate laboratory documentation.
  • Experience with method validation/qualification, equipment troubleshooting, calibration, and preventative maintenance support.
  • Strong analytical, troubleshooting, organizational, and written communication skills, including preparation of technical reports.
  • Commitment to laboratory safety, compliance, product quality, and continuous improvement.

Neogen Corporation Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Neogen Corporation and has not been reviewed or approved by Neogen Corporation.

  • Healthcare Strength The benefits suite includes comprehensive medical, dental and vision coverage, plus disability, life insurance, and an Employee Assistance Program. These core coverages are consistently described as a relative bright spot.
  • Retirement Support A defined-contribution 401(k) with company match and immediate vesting is highlighted, alongside standard retirement and savings programs. This structure provides clear baseline retirement support for eligible roles.
  • Equity Value & Accessibility An employee stock purchase plan offers discounted access to company shares. This adds an ownership pathway that complements cash compensation.

Neogen Corporation Insights

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The Company
HQ: Lansing, MI
1,160 Employees
Year Founded: 1982

What We Do

NEOGEN Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, genetic modifications, food allergens, drug residues, plant diseases and sanitation concerns. NEOGEN’s Animal Safety Division markets a complete line of diagnostics, veterinary instruments, veterinary pharmaceuticals, nutritional supplements, disinfectants and rodenticides.

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