Job Description

Position Title: QC Microbiologist

Work Location: Social Circle, GA

Assignment Duration: 06 Months

Work Arrangement: Onsite — 100%

Key Responsibilities:

• 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.
• 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.
• 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.
• Oversee qualification and onboarding of analytical equipment for microbiology and analytical testing.
• Utilize and maintain electronic laboratory systems such as MODA and LabWare LIMS.
• 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.

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