Laboratory Validation Analyst

OVERVIEW 1 to 3 years of experience in quality assurance for an analytical or environmental or other chemical laboratory. POSITION DESCRIPTION The Indiana Dept of Health Chemistry Lab is implementing a new Laboratory Information Management System (LIMS) which needs to meet complicated reporting requirements for quality control and quality assurance for our customers. A quality assurance coordinator is required to work with program developers to ensure that all chemical quality assurance requirements are captured in the correct electronic formats, with an emphasis on traceability and validation of the system. The QAC also will do in-depth review of chemistry data packages for Indiana Dept of Environmental Management, Lead & Healthy Homes, EPA, and FDA packages for the Laboratory Flexible Funding Model grant as well as reviewing all chemistry procedures for method deviations from published methods and evaluate chemical inventory systems. A goal also is to validate Excel spreadsheets that are used for analytical calculations and review annual competencies of 25 chemists for about 60 methods. Writes, revises, and verifies quality standards for program design and product evaluation to attain quality of software economically and efficiently. Evaluates program output and reports for accuracy, and policies and procedures for quality. Recommends program improvements or corrections to programmers. Identifies differences between establishment standards and user applications and suggests modifications to conform to standards. The use of AI is expected and includes the development of laboratory AI procedures for spreadsheet validations and standard operating procedure validations. EXPERIENCE DESCRIPTION Quality Assurance Analyst capabilities with approximately 1-3 years of experience in the field or in a related area. Has knowledge of commonly used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job.