Laboratory Informatics Analyst

Role Summary

To support our continued growth, Quanterix Accelerator is seeking a highly motivated CSV/Laboratory Informatics Analyst to join our Laboratory Operations organization. This hybrid role bridges laboratory operations, quality systems, and informatics, supporting the execution of biomarker, translational, and clinical testing services within a regulated laboratory environment.

What You’ll Do

• Translate laboratory needs into clear, structured requirements for LIMS bug fixes, enhancements, and operational improvements.
• Partner with laboratory leadership to prioritize system improvements, define roadmaps, and align with business and operational goals.
• Serve as the primary liaison with corporate IT, LIMS vendors and development partners, including defining scope, timelines, and level of effort (LOE).
• Track and report progress of LIMS changes, including story status (draft, DEV, VAL, production) and categorization (bug fix, quality, operational improvement).

Validation and Documentation

• Author and execute validation protocols and scripts for LIMS updates (IQ/OQ/PQ or fit-for-purpose validation aligned with CLIA/CAP expectations).
• Perform DEV testing and coordinate VAL execution with laboratory staff, ensuring reproducibility and traceability.
• Support change control processes, ensuring all system updates meet regulatory and quality requirements.
• Develop and maintain validation documentation including:
  • Validation Plans
  • Requirements Specifications
  • IQ/OQ/PQ protocols
  • Traceability Matrices
  • Validation Summary Reports
  • Regression testing documentation
• Maintain organized validation records and testing evidence within document management systems.

LIMS System Administration

• Act as LIMS system administrator, providing daily support including:
• User access and login troubleshooting
• Instrument interface connectivity resets
• Initial investigation of system errors impacting lab workflows

Operational Support

• Identify root causes of system issues and implement corrective and preventive actions (CAPA) where applicable.
• Collaborate with laboratory scientists to ensure LIMS accurately reflects:
• Sample workflows and chain of custody
• Assay execution (e.g., ELISA, immunoassays)
• Data capture, QC processes, and reporting outputs

Development and Maintenance

• Maintain and configure test methods, panels, instrument integrations, and master data within LIMS.
• Develop and maintain operational dashboards and reports (e.g., TAT, throughput, QC trends, error rates).
• Support data integrity initiatives and continuous improvement of laboratory metrics.

Broad LIMS/IT Initiatives

• Support broader LIMS/IT initiatives and system upgrades as bandwidth allows.
• Work closely with IT and external partners to ensure scalable and robust system architecture.
• Support audit and inspection readiness activities related to laboratory informatics systems.
• Aid in documentation retrieval and validation evidence reviews.
• Ensure software validation records remain current, complete, and compliant.

BASIC QUALIFICATIONS

• Bachelor’s degree in biology, Chemistry, Clinical Laboratory Science, Computer Science, or related field.
• 5+ years of experience.
• 2+ years of experience with LIMS/LIS systems in a laboratory environment.

PREFERRED QUALIFICATIONS

• Experience with LIMS configuration, scripting, or system engineering.
• Hands-on laboratory experience with clinical or translational workflows (e.g., ELISA, immunoassays, or similar) and/or experience supporting software validation activities within regulated laboratory environments.
• Experience supporting regulated environments (CLIA, CAP, GxP).
• Experience with:
  • IQ/OQ/PQ documentation
  • Software testing
  • Requirements traceability
  • Change management
• Strong understanding of laboratory workflows, data integrity, and quality systems.
• Proven ability to translate operational needs into technical requirements.
• Excellent problem-solving, communication, and organizational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Familiarity with instrument integrations and data pipelines.
• Experience in validation methodologies (IQ/OQ/PQ, software validation).
• Certification as MLS/MT (ASCP or equivalent).
• Experience in biomarker, clinical trial, or CRO environments.
• Exposure to dashboarding tools (e.g., Power BI) or data analysis workflows.
• Experience supporting LabVantage LIMS, LabVantage Analytics, and/or Physician’s Portal.
• Familiarity with ServiceNow, JIRA, or similar project tracking tools.

COMPENSATION AND BENEFITS

Pay Range: $100,000 - $120,000 per year

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