QC Microbiology Supervisor

BioPharma Consulting JAD Group • Fort Worth, TX

12h

About The Position

Lead biological and microbiological quality control testing at a global pharmaceutical manufacturer in Fort Worth, Texas. The role includes conducting and overseeing routine and non-routine microbiological analyses of raw materials, in-process materials, environmental samples, finished goods, and stability samples. It also involves developing, qualifying, validating, and transferring microbiological and biological methods, including microbial limits, endotoxin, and cell-based assays. The supervisor trains analysts, leads out-of-specification and contamination investigations, prepares quality documentation and microbial trend analyses, coordinates testing with contract laboratories, and supports audits.

Requirements

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

Nice To Haves

• Supervisory or lead experience.
• Experience with PCR, ELISA, or flow cytometry.

Responsibilities

• Conduct and oversee routine and non-routine microbiological analyses of raw materials, in-process materials, environmental samples, finished goods, and stability samples.
• Develop, qualify, validate, and transfer microbiological and biological methods, including microbial limits, endotoxin, and cell-based assays.
• Train analysts.
• Lead out-of-specification and contamination investigations.
• Write SOPs, protocols, and deviation reports, and prepare microbial trend analyses.
• Coordinate testing with contract laboratories.
• Support audits.

What This Job Offers

• Career Level: Manager