Microbiology Tech Lead - GMP QC, 2nd Shift

Kincell Bio, LLC; Gainesville (FL); On-site; USD 39,000 - 52,000; Part time

Job summary

Kincell Bio in Gainesville, FL is seeking a highly motivated Microbiology Technician Lead to join a collaborative Quality Control team on a contract basis. You will support day-to-day environmental monitoring, microbial testing, and sample coordination with outside labs, ensuring aseptic manufacturing facility controls.

The role requires leading microbiology activities, troubleshooting methods and equipment, and partnering with QA, Manufacturing, and Validation.

Qualifications

• Bachelor’s degree in microbiology, biology, or a related scientific discipline with GMP-regulated lab experience.
• Hands-on environmental monitoring experience in classified cleanroom environments.
• Aseptic gowning experience in cleanrooms and GMP environments.
• Proficiency in microbiological testing (sterility, endotoxin, enumeration, osmolality, pH).
• Ability to lead, mentor, and supervise microbiology personnel.
• Knowledge of GMP, data integrity, contamination control, and regulatory expectations.
• Proficiency with Microsoft Office applications.
• Strong organizational, analytical, and problem-solving skills; ability to manage multiple activities.

Responsibilities

• Provide day-to-day technical leadership for microbiology and environmental monitoring activities in GMP manufacturing.
• Coordinate daily workload and prioritize environmental monitoring, QC testing, investigations, and other lab activities.
• Serve as technical resource and backup for microbiology methods and testing, maintaining proficiency in relevant assays.
• Perform microbiological testing to support operations, schedules, and investigations.
• Conduct environmental monitoring in classified areas, including air, surface, and personnel monitoring.
• Perform sterility testing, method verification, and method suitability activities including BacT/ALERT 3D testing.
• Maintain and troubleshoot microbiology equipment, coordinate calibration and servicing.
• Assist with microbiology investigations and root-cause analyses; support CAPAs.
• Review records for accuracy and data integrity; ensure procedures compliance.
• Collaborate with QA, Manufacturing, Engineering, Validation for investigations and contamination control.
• Ensure all activities comply with company policies, SOPs, GMP, and regulatory expectations.

Skills

Technical leadership

Environmental monitoring

Data analysis

Communication skills

Microsoft Office

Education

Bachelor's degree in microbiology or related field

Tools

BacT/ALERT 3D System

Job description

Kincell Bio in Gainesville, FL is seeking a highly motivated Microbiology Technician Lead to join a collaborative Quality Control team on a contract basis. You will support day-to-day environmental monitoring, microbial testing, and sample coordination with outside labs, ensuring aseptic manufacturing facility controls.

The role requires leading microbiology activities, troubleshooting methods and equipment, and partnering with QA, Manufacturing, and Validation.