Senior Microbiology QC Technician - Cleanroom & GMP

Kincell Bio, LLC; North Carolina; On-site; USD 60,000 - 85,000; Full time

Job summary

Kincell Bio seeks a highly motivated QC Microbiology Technician III to join our Durham, NC on-site team supporting aseptic manufacturing and environmental monitoring. The role involves routine environmental monitoring of cleanrooms, microbial assays, data trending, and coordination with outside laboratories to ensure GMP compliance and timely release of products.

You will work with manufacturing to maintain quality systems and perform testing including bioburden and endotoxin assays.

Qualifications

• Bachelor’s degree in microbiology or related field with 2+ years of lab experience.
• Experience performing environmental monitoring in cleanrooms or controlled environments.
• Hands-on aseptic gowning in classified cleanrooms environments.
• Experience performing GMP-regulated microbiology tests.

Responsibilities

• Perform routine environmental monitoring of cleanrooms and laboratory areas.
• Perform microbiological testing including bioburden and endotoxin.
• Coordinate testing with external contract laboratories.
• Maintain laboratory supplies and data trending.
• Prepare microbiological media, buffers, reagents, and related materials.
• Assist with investigations and CAPA related to microbiology events.

Skills

Environmental monitoring

Aseptic gowning

Microbiological testing

GMP compliance

Data analysis

Trend analysis

Report generation

Equipment qualification

Attention to detail

Microsoft Office

Off-hours work

Education

Bachelor’s degree in microbiology

Tools

BacT/ALERT 3D System

LIMS (laboratory information management system)

Job description

Kincell Bio seeks a highly motivated QC Microbiology Technician III to join our Durham, NC on-site team supporting aseptic manufacturing and environmental monitoring. The role involves routine environmental monitoring of cleanrooms, microbial assays, data trending, and coordination with outside laboratories to ensure GMP compliance and timely release of products.

You will work with manufacturing to maintain quality systems and perform testing including bioburden and endotoxin assays.