Laboratory Informatics Analyst (LIMS & Clinical Operations)

Location: Bedford, MA

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.

The ideal candidate combines hands-on laboratory experience (e.g., ELISA, immunoassays, or translational testing workflows) with strong expertise in Laboratory Information Management Systems (LIMS/LIS), system validation, workflow configuration, and operational support. This individual will serve as a critical interface between laboratory operations, IT, quality, and external vendors to ensure laboratory informatics systems effectively support scalable, compliant, and high-quality testing operations.

This role will support Computer Systems Validation (CSV) activities for laboratory informatics platforms including LabVantage LIMS, LabVantage Analytics, and Physician's Portal, ensuring systems remain compliant, validated, and inspection ready within CLIA/CAP/GxP/FDA regulated environments.

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).

• 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.
• Author, review, and maintain validation documentation including:
  • Validation Plans
  • Requirements Specifications
  • IQ/OQ/PQ protocols
  • Traceability Matrices
  • Validation Summary Reports
  • Regression testing documentation
• Ensure validation documentation aligns with internal quality procedures and regulatory requirements.
• Coordinate validation testing activities across DEV and VAL environments.
• Develop and execute test scripts supporting end-to-end workflow validation.
• Maintain traceability between requirements, testing, deviations, and approvals.
• Support regression testing activities for software updates and enhancements.
• Support software change control processes and impact assessments.
• Coordinate validation deliverables with QA, IT, laboratory operations, and vendors.
• Maintain organized validation records and testing evidence within document management systems.

• 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
• 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
• 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.

• 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.
• Assist with 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.
• Min 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.

EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:

• Work location: Hybrid role based in Bedford, MA.
• Travel: Minimal travel required.
• Ability to work effectively across laboratory operations, quality, IT, and external vendor teams.
• Strong analytical, documentation, troubleshooting, and organizational skills with attention to detail in regulated environments.
• Must be able to remain stationary for extended periods and occasionally move standard laboratory or office materials as needed.

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