SPECTRAFORCE
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.