QC Microbiologist
On-siteLexington, Kentucky, United States
Job Summary
Conduct routine microbiological testing for raw materials, finished products, and stability samples in accordance with GLP/cGMP requirements. Administer the environmental monitoring program, maintain laboratory hygiene standards, and investigate microbial data deviations by documenting findings and preparing presentation-quality reports. Support equipment troubleshooting, validation, qualification, and calibration while writing, reviewing, and revising laboratory documentation including SOPs, protocols, and deviation reports. Participate in quality system activities such as audits, batch record reviews, CAPA activities, and data trending to ensure regulatory compliance and operational excellence.
Required Qualifications
- Bachelor's degree in Microbiology, Biology, Biotechnology, or a related scientific discipline
- 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 laboratory documentation with a high level of accuracy and attention to detail
- Strong analytical, troubleshooting, organizational, and written communication skills, including the ability to prepare clear technical reports
- Commitment to laboratory safety, compliance, product quality, and continuous improvement
Desired Qualifications
- Bachelor's degree in Microbiology, Biology, Biotechnology, or a related scientific discipline preferred; equivalent relevant laboratory experience may be considered
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