Laboratory Informatics Analyst (LIMS & Clinical Operations)
Location: Bedford, MA
Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With more than 3,400 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades. In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company®, adding multiplexed tissue imaging with single-cell resolution to its portfolio. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics.
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.
WHY YOU’LL LIKE WORKING WITH US:
Our Technology:
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.
Akoya Biosciences, a Quanterix company, is The Spatial Biology Company®—bringing tissue context to life through high-resolution, single-cell imaging. Akoya’s spatial phenotyping platforms help researchers visualize and measure how cells organize and interact within tissue to influence disease progression and therapeutic response. From discovery through clinical research, Akoya offers a full continuum of solutions, including PhenoCycler®, PhenoImager® Fusion and HT, and PhenoCode™ Panels. As part of Quanterix, Akoya complements a leading portfolio of ultra-sensitive biomarker detection technologies, together enabling a more complete view of biology and disease across both tissue and blood.
Our Commitment to Employees:
At Quanterix, our values are based on: Team, Innovation, Customer and Owner.
Team: Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards.
Innovation: Stay curious, experiment, create and change.
Customer: Prioritize and celebrate these pioneers by doing our best to deliver on commitments.
Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures.
We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible for equity, employee stock purchase plan, a performance bonus, and 1:1 financial counseling/planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day!
DIVERSE & INCLUSIVE WORKPLACE:
Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.
Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
