Job Overview:

We are looking for a skilled and detail-oriented Lab Data Analyst with experience in laboratory systems such as LIMS, LIS (e.g., ULTRA), and CTMS. The ideal candidate will bring deep expertise in lab data management, system configuration, validation, and compliance with regulatory standards such as 21 CFR Part 11. This role is critical in ensuring data integrity, system functionality, and cross-team collaboration to support high-quality laboratory operations.

✔️ Experience: 4+ years
✔️ Location: Remote - India
✔️ Interview levels: 3 interview rounds
✔️ Salary: As per market standards
✔️ Type: Contract:- 1 year, Renewable

Key Responsibilities:

• Analyze and manage laboratory data across multiple systems including ULTRA, LIMS, and CTMS.
• Configure laboratory computer systems based on Instrument Request Forms (IRFs).
• Validate test codes and perform end-to-end validation between LIS and reporting systems.
• Ensure systems are compliant with FDA regulations, particularly 21 CFR Part 11.
• Serve as the liaison between IT and laboratory teams to ensure seamless integration and functionality.
• Read and interpret HL7 messages; work with interface engines like Corepoint.
• Maintain high standards in data accuracy, integrity, and reporting.
• Perform lab system validation activities including documentation, testing, and review.
• Provide insights through data analysis and contribute to lab process improvements.
• Manage multiple priorities and projects independently under tight timelines.
• Prepare and present reports, summaries, and documentation to stakeholders.

Requirements:

• 4+ years of experience in laboratory data analysis and lab system validation.
• Hands-on experience with lab systems such as ULTRA/LIS, LIMS, and CTMS.
• Strong understanding of 21 CFR Part 11 and validation protocols.
• Proficiency in Corepoint and interpreting HL7 messages.
• Excellent knowledge of Microsoft Excel and Word.
• Strong analytical and troubleshooting skills with a high attention to detail.
• Excellent written and verbal communication skills.
• Proven ability to work independently and manage multiple tasks effectively.
• Experience in collaborating with cross-functional teams and synthesizing technical information.

Preferred Qualifications:

• Experience supporting lab informatics systems in regulated environments.
• Familiarity with automation or scripting for data handling.
• Exposure to data integration projects involving clinical or research systems.

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