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Microbiology Group Leader

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

This role provides leadership for rapid sterility testing, traditional sterility testing, bacterial endotoxin testing, environmental monitoring, aseptic technique programs, gowning certification, and other microbiology-based laboratory services. The Microbiology Group Leader works closely with Quality Assurance, laboratory leadership, and cross-functional teams to ensure accurate testing, strong documentation, audit readiness, and continuous improvement.

Location: Onsite

Primary Responsibilities

Microbiology Laboratory Leadership

• 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.
• Assist in the implementation of new equipment, methods, room qualifications, utility qualifications, and related microbiology projects.

Microbiological Testing and Technical Support

• 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.

Compliance, Documentation, and Quality Systems

• 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.

Training, Programs, and Inspection Support

• 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.

Core Competencies

• Leadership and Team Development: Guides team members and supports a positive, productive work environment focused on continuous improvement.
• Regulatory Expertise: Demonstrates knowledge of ISO, FDA, USP, cGMP standards, and FDA System Based Inspection Policy.
• Technical Proficiency: Applies expertise in pharmaceutical microbiology testing, including ScanRDI, traditional sterility, endotoxin testing, and environmental monitoring.
• Problem Solving: Troubleshoots and resolves complex microbiological and operational challenges.
• Communication and Documentation: Prepares clear technical documentation and communicates effectively during inspections, audits, and client interactions.

Desired 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.

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