QC Microbiology Supervisor

We are seeking a QC Microbiology Supervisor to lead biological and microbiological quality control testing at a pharmaceutical manufacturing site in Fort Worth, Texas.

Key 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 (microbial limits, endotoxin, cell-based assays).
• Train analysts in microbiological procedures and biological assays.
• Participate in 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 lab cleanliness and biosafety standards; troubleshoot incubators, autoclaves and biosafety cabinets.
• Support internal assessments, audits and regulatory submissions.

Requirements

• Required Qualifications
• Bachelor's degree in Microbiology, Biology or related science
• Experience in a GMP QC Microbiology laboratory (environmental monitoring, microbial limits, endotoxin)
• Experience with method validation/transfer and OOS/deviation investigations
• Technical writing: SOPs, protocols and reports

Preferred Qualifications

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