USA - Scientist

USA - Scientist#25-68360

Social Circle, GA

All On-site

Job Description

Actual Job Title - QC Microbiologist Specialist

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.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.