QA Analyst: LIMS & Data Validation Specialist

MillenniumSoft Inc; Indianapolis (IN); On-site; USD 52,000 - 71,000; Full time

Job summary

MillenniumSoft Inc offers a Quality Assurance Analyst role in Indianapolis, IN, focused on validating LIMS, EPA methods, and data integrity. You will collaborate with chemists and developers to ensure traceability and compliance across laboratory quality systems.

The position emphasizes hands-on data validation, program reviews, and system testing within a manufacturing-lean QA environment. Indiana-based duties require attention to regulatory standards and accurate documentation.

Qualifications

• 1-3 years of quality assurance experience in an analytical, environmental, or other chemical laboratory.
• Working knowledge of commonly used concepts, practices, and procedures in the field.
• Experience supporting LIMS implementation, testing, and validation.
• Compliance knowledge of EPA, FDA, and state environmental regulatory standards.

Responsibilities

• Revise and improve existing Python code and data operations for efficiency and integration into the LIMS (STARLIMS).
• Write, revise, and verify quality program standards based on EPA chemistry test methods, using accuracy data to validate results.
• Review and design features for efficient laboratory operation.
• Review new or modified programs, including documentation and specifications, to ensure they perform as requested and comply with guidelines.
• Recommend program improvements or corrections to programmers; identify differences between standards and user applications and suggest modifications.
• Conduct in-depth reviews of chemistry data packages for Indiana Dept of Environmental Management, Lead & Healthy Homes, EPA, and FDA (Laboratory Flexible Funding Model grant).
• Review chemistry procedures for deviations from published methods; evaluate chemical inventory systems.
• Validate Excel spreadsheets used for analytical calculations.
• Review annual competencies of 25 chemists across about 60 methods.
• Collaborate with IT and development teams on LIMS implementation and validation; participate in system testing, identifying defects and recommending improvements.
• Verify completeness, accuracy, and adherence to reporting guidelines for externally submitted lab results.
• Maintain validated electronic records and consistent documentation to ensure data traceability and integrity.
• Review system outputs and audit trails to confirm data accuracy and QA compliance.

Skills

Python programming

LIMS validation and integration

EPA chemistry test methods and data

Regulatory data package review

Excel spreadsheet validation

Communication with chemists and devs

Traceability and audit trails

Tools

STARLIMS

Job description

MillenniumSoft Inc offers a Quality Assurance Analyst role in Indianapolis, IN, focused on validating LIMS, EPA methods, and data integrity. You will collaborate with chemists and developers to ensure traceability and compliance across laboratory quality systems.

The position emphasizes hands-on data validation, program reviews, and system testing within a manufacturing-lean QA environment. Indiana-based duties require attention to regulatory standards and accurate documentation.