SPECTRAFORCE
Position Title: QC Microbiologist
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. 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.
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. 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.