Microbiology Group Leader

About the role

The Microbiology Group Leader supports Prompt Praxis Laboratories microbiology testing operations by overseeing daily department activities, managing testing schedules, supporting investigations, and helping maintain compliance in a cGMP-regulated laboratory environment.

Responsibilities

• Oversee daily operations and address the needs of the Microbiology Department.
• Manage testing schedules, testing progress, data, and work quality.
• Support department planning, prioritization, and project timelines.
• Provide continuous improvement ideas to strengthen laboratory efficiency, quality, and compliance.
• Aid in the implementation of new equipment, methods, room qualifications, utility qualifications, and related microbiology projects.
• Provide microbiology support for rapid sterility testing, including ScanRDI, traditional sterility testing, bacterial endotoxin testing, and other microbiological testing as required.
• Apply strong knowledge of pharmaceutical microbiology, cleanroom environmental control, and microbiological testing methods.
• Support environmental monitoring of clean rooms and utilities.
• Participate in troubleshooting and out-of-specification investigations for the Microbiology Department.
• Develop strong microbiology and investigational skills within the department.
• Support compliance with ISO, FDA, USP, cGMP, and related regulatory expectations.
• Help Quality Assurance establish and enforce quality standards in sample testing and documentation.
• Revise and review SOPs, checklists, investigations, validations, and related technical documents.
• Ensure documentation clearly defines the steps needed to complete required audit tasks.
• Participate in client and internal audits based on the FDA System Based Inspection Policy and general cGMP expectations.
• Assist in the creation, implementation, and administration of microbiology-based programs, including training, gowning, and aseptic technique programs.
• Represent Microbiology during regulatory inspections and respond to microbiology-related questions, issues, and solutions.
• Respond to customer requests for information.
• Develop professional and technical knowledge through continuing education, professional publications, networking, and industry participation.

Qualifications

• Bachelor's degree in Microbiology.
• 3+ years of directly related experience required.
• Solid working knowledge of cGMPs and related quality systems.
• Knowledge of pharmaceutical microbiology, including ScanRDI, traditional sterility, and endotoxin testing.
• Experience in environmental control and monitoring of clean rooms and utilities.
• Technical writing experience, including SOPs, investigations, and validations.
• Strong organizational, oral communication, problem-solving, attention to detail, and interpersonal skills.
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
• Ability to exercise initiative and judgment to solve problems of varying difficulty.