Currently we have an opening for a QC Microbiologist Specialist located in Social Circle, GA. Details for the position are as follows:
Pay Range: $50-$83/hour
Job Description:
Pay Range: $50-$83/hour
Job Description:
- 6-month contract with the possibility of extending or converting to permanent based on performance and budget.
- 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.
- BS/MS/PhD
- At least 3+ years of hands on experience within a QC Microbiology environment
- Strong understanding of QC Microbiology