QA Tester

About the Role

Works with developers and chemists to ensure that all quality assurance requirements are captured in the correct electronic formats, with an emphasis on traceability and validation of a laboratory information management system.

1 to 3 years of experience in quality assurance for an analytical, environmental, or other chemical laboratory.

The Indiana Department of Health Chemistry Lab is implementing a new Laboratory Information Management System (LIMS). The quality assurance coordinator will work with program developers to capture all chemical quality assurance requirements in the correct electronic formats, validate traceability, and ensure system accuracy. The coordinator will review chemistry data packages (for the Indiana Department of Environmental Management, Lead & Healthy Homes, EPA, and FDA), evaluate compliance with method deviations from published methods, assess chemical inventory systems, validate Excel spreadsheets used for analytical calculations, and review annual competencies of 25 chemists across approximately 60 methods.

Additional responsibilities include writing, revising, and verifying quality standards for program design and product evaluation, evaluating program output and reports, recommending program improvements, and identifying differences between establishment standards and user applications to suggest modifications.

The use of AI is expected; the coordinator will develop laboratory AI procedures for spreadsheet validations and SOP validations.

• LIMS Validation & Traceability
• Chemical Quality Assurance Requirements
• Chemistry Data Package Review
• Method Deviation Evaluation
• Chemical Inventory System Assessment
• Spreadsheet Validation (Excel)
• Competency Assessment for Chemists
• SOP Validation & Development
• AI-Driven Validation Procedures
• Regulatory Reporting (EPA, FDA, Indiana Dept of Environmental Management)
• Effective communication with chemists and program developers

• Laboratory Information Management System (LIMS)
• Microsoft Excel (Advanced)
• AI / Machine Learning for Validation
• Validation Software Tools
• Quality Management System (QMS) Platforms
• Electronic Data Capture (EDC) Systems

• Bachelor's Degree in Chemistry, Biochemistry, Environmental Science, Analytical Chemistry, Quality Assurance, Laboratory Science.
• Preferred:
  Master's in Chemistry, Master's in Quality Assurance, Master's in Regulatory Science, PhD.

• Public Health Laboratory
• Environmental Chemistry
• Regulatory Compliance
• Government Laboratory
• Analytical Chemistry