Senior QC Microbiology Technician, GMP & Cleanroom

Kincell Bio; Durham (NC); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

Kincell Bio in Durham, NC, is seeking a QC Microbiology Technician III to join our on‑site Quality Control team. You will perform environmental monitoring of cleanrooms, microbiological testing of materials, and data trending to ensure aseptic manufacturing control.

You will coordinate with external labs and support investigations, method validation, and equipment qualification while maintaining compliance with GMP and data integrity principles.

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.
• Experience performing environmental monitoring in a classified cleanroom or controlled environment.
• Hands‑on experience with aseptic gowning and working within classified cleanroom environments.
• Experience performing microbiological testing in a GMP‑regulated, pharmaceutical, biotechnology, cell therapy, or similarly regulated environment.
• Experience with environmental monitoring methods and various assays (bioburden, endotoxin, microbial enumeration, growth promotion, Gram staining, subculture techniques, microbial identification, and/or sterility testing).

Responsabilités

• 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.
• Perform environmental monitoring activities during off-hours, weekends, and other non-standard schedules as required to support manufacturing operations.
• Serve as a senior technical resource for microbiology and environmental monitoring activities and provide guidance and support to other microbiology personnel as needed.
• Perform critical utility microbiological monitoring in accordance with approved procedures, specifications, and established schedules.
• Perform microbiological QC testing of raw materials, in-process materials, and other applicable samples in accordance with approved procedures and GMP requirements.

Connaissances

Environmental monitoring

Aseptic gowning

Data analysis

Problem-solving

Formation

Bachelor's degree in microbiology or related

5+ years experience in lieu of degree

Outils

LIMS

BacT/ALERT 3D System

Microsoft Office

Description du poste

Kincell Bio in Durham, NC, is seeking a QC Microbiology Technician III to join our on‑site Quality Control team. You will perform environmental monitoring of cleanrooms, microbiological testing of materials, and data trending to ensure aseptic manufacturing control.

You will coordinate with external labs and support investigations, method validation, and equipment qualification while maintaining compliance with GMP and data integrity principles.