Senior QC Microbiology Technician, Environment & Sterility

Kincell Bio, LLC; Durham, Northern (NC, KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Kincell Bio, LLC in Durham, NC is seeking a highly motivated Microbiology Technician III to support the Quality Control team with environmental monitoring and microbiology testing in a GMP environment. The role emphasizes aseptic technique, data trending, and collaboration with manufacturing to ensure aseptic conditions.

The position requires a Bachelor’s degree in microbiology or related field with relevant lab experience or 5 years in lieu of a degree, and will involve off-hours work as needed

Qualifications

• Bachelor’s degree in microbiology, biology, or another relevant scientific discipline with a minimum of 2 years of relevant microbiology laboratory experience, or a minimum of 5 years of relevant microbiology laboratory experience in lieu of a degree.
• Demonstrated experience performing environmental monitoring in a classified cleanroom or controlled environment.
• Hands-on experience with aseptic gowning and working within classified cleanroom environments.
• Demonstrated experience performing microbiological testing in a GMP-regulated, pharmaceutical, biotechnology, cell therapy, or similarly regulated environment.
• Experience with applicable microbiological methods, including environmental monitoring, bioburden, bacterial endotoxin, microbial enumeration, growth promotion, Gram staining, subculture techniques, microbial identification, and/or sterility testing.
• Experience with microbiology investigations, environmental monitoring excursions, atypical results, or out-of-specification events preferred.
• Experience with microbiological data analysis, trending, and technical report generation.
• Experience supporting microbiology equipment, method, or process qualification and validation activities preferred.

Responsibilities

• Perform routine and non-routine environmental monitoring of classified cleanrooms and laboratory areas, including viable air, surface, personnel, compressed gas, and other applicable monitoring, in support of GMP manufacturing operations.
• Coordinate sample submission and results review with external contract laboratories to ensure timely data.
• Perform microbiological testing including bioburden, bacterial endotoxin, microbial enumeration, Gram staining, microbial identification, and sterility testing.
• Assist with investigations, deviations, and trending of microbiology data to support continuous improvement.
• Maintain lab supplies, data trending, and preparation of technical reports and scientifically sound conclusions.

Skills

Environmental monitoring

GMP

Microbiology testing

Aseptic gowning

Data trending

Technical guidance

LIMS

Bioburden

Sterility testing

Education

Bachelor’s degree in microbiology or related field

2 years microbiology lab experience

5 years experience in lieu of degree

Tools

BacT/ALERT 3D System

Laboratory Information Management System (LIMS)

Job description

Kincell Bio, LLC in Durham, NC is seeking a highly motivated Microbiology Technician III to support the Quality Control team with environmental monitoring and microbiology testing in a GMP environment. The role emphasizes aseptic technique, data trending, and collaboration with manufacturing to ensure aseptic conditions.

The position requires a Bachelor’s degree in microbiology or related field with relevant lab experience or 5 years in lieu of a degree, and will involve off-hours work as needed