QC Microbiology Supervisor

BioPharma Consulting JAD Group • Fort Worth, TX

4d • Onsite

About The Position

The QC Microbiology Supervisor leads biological and microbiological quality control testing at a pharmaceutical manufacturing site in Fort Worth, Texas. The role conducts and oversees testing of raw materials, in-process materials, environmental samples, finished goods, and stability samples. It also develops, qualifies, validates, and transfers microbiological and biological methods, including microbial limits, endotoxin, and cell-based assays.

The supervisor trains analysts, supports investigations and corrective actions, prepares and revises laboratory documentation, reviews contract laboratory data, and coordinates testing with contract labs and vendors. The role maintains laboratory cleanliness and biosafety standards, troubleshoots laboratory equipment, and supports internal assessments, audits, and regulatory submissions.

Requirements

• Bachelor's degree in Microbiology, Biology, or a related science.
• Experience in a GMP QC Microbiology laboratory, including environmental monitoring, microbial limits, and endotoxin.
• Experience with method validation or transfer and OOS or deviation investigations.
• Technical writing experience with SOPs, protocols, and reports.

Nice To Haves

• Supervisory or lead experience, including training analysts.
• Experience with PCR, ELISA, or flow cytometry.
• Experience managing contract laboratories.
• Experience with statistical trending of microbiological data.

Responsibilities

• Conduct and oversee routine and non-routine microbiological analyses of raw materials, in-process, environmental, finished goods, and stability samples.
• Develop, qualify, validate, and transfer microbiological and biological methods, including microbial limits, endotoxin, and cell-based assays.
• Train analysts in microbiological procedures and biological assays.
• Participate in out-of-specification (OOS) and contamination investigations and recommend corrective actions.
• Write and revise SOPs, protocols, deviation reports, and microbial trend analyses.
• Review contract laboratory data and coordinate testing with contract labs and vendors.
• Maintain laboratory cleanliness and biosafety standards.
• Troubleshoot incubators, autoclaves, and biosafety cabinets.
• Support internal assessments, audits, and regulatory submissions.

What This Job Offers

• Career Level: Manager