QC Microbiologist Specialist
- Social Circle, GA
- $72.00-77.70 per hour
- Permanent
- Full-time
Onsite - 100%Microbiology Testing & Method Lifecycle
*Perform and oversee GMP microbiological testing for raw materials, intermediates, and finished products.
*Lead method development, validation, and transfer activities in compliance with compendial and regulatory standards.
*Manage trending and analysis of assay controls and invalid assay results to identify patterns and drive continuous improvement.Environmental Monitoring & Data Trending
*Implement and maintain environmental monitoring programs for cleanrooms and controlled areas.
*Perform statistical analysis of monitoring data using Minitab or similar tools to assess state of control.Quality Systems & Compliance
*Lead and manage change control activities impacting QC processes and analytical methods.
*Conduct and document laboratory investigations in TrackWise;develop and implement CAPAs.
*Ensure alignment with USP, EP, and applicable regulatory agency guidelines.Equipment & Technology Management
*Oversee qualification and onboarding of analytical equipment for microbiology and analytical testing.
*Utilize and maintain electronic laboratory systems such as MODA and LabWare LIMS.Project & Documentation Management
*Lead cross-functional QC projects, including continuous improvement initiatives and technology upgrades.
*Author and review technical documents, including protocols, SOPs, final reports, and data summaries.
*Present data and recommendations to management and regulatory inspectors as needed.