Quality Control Microbiology Analyst

Job - Quality Assurance Technician

Location: Onsite – Bogart, GA

Duration: 12 Months (Possibility of extension)

Role Overview

The Quality Control (QC) Analyst I supports both commercial and clinical manufacturing by performing microbiology testing and ensuring compliance with cGMP (current Good Manufacturing Practices) .

The role is part of the QC Microbiology team , focusing on testing raw materials, biological samples (including egg white-based materials), and supporting overall laboratory quality systems.

Key Responsibilities

Microbiology Testing

• Perform routine microbiology testing such as:
• Bioburden testing
• Endotoxin testing
• Microbial identification
• Growth promotion testing
• Support environmental monitoring and utility monitoring programs
• Assist with product testing, qualifications, and investigations

Compliance and Documentation

• Follow written SOPs (Standard Operating Procedures) strictly
• Maintain accurate, real-time laboratory records in compliance with cGMP
• Identify abnormal test results or sample issues and report them to supervisors
• Contribute to investigation reports and documentation when issues arise

Laboratory Support

• Prepare and maintain laboratory reagents and solutions
• Clean, maintain, and support laboratory equipment
• Order, stock, label, and manage inventory of lab supplies

Training and Collaboration

• Train other lab personnel when required
• Attend all required company training sessions
• May assist in reviewing laboratory data or documentation

Required Qualifications

• Bachelor’s degree or higher in Biology or Microbiology
• 0–2 years of experience in QC Microbiology or related lab environment

Technical Skills and Knowledge

• Aseptic technique
• Microbiological testing methods:
• Bioburden
• Endotoxin
• Microbial identification
• Growth promotion testing
• Environmental monitoring
• Cell culture (preferred)
• Understanding of cleanroom practices and laboratory instrumentation
• Familiarity with cGMP regulations and application in lab settings

Key Competencies

• Strong attention to detail and accuracy in documentation
• Ability to follow SOPs strictly and work independently with minimal supervision
• Strong organizational skills for managing routine lab tasks
• Clear verbal and written communication skills
• Ability to troubleshoot laboratory assays and equipment issues
• Ability to provide status updates and track assigned tasks

Summary

This is a hands-on microbiology QC laboratory role focused on ensuring product and process quality in a regulated pharmaceutical environment. The position requires strong lab discipline, regulatory awareness (cGMP), and practical microbiology skills, with responsibilities spanning testing, documentation, compliance, and basic lab operations