Laboratory Information Management System

About the role

You will own the end to end testing of our Laboratory Information Management System ensuring that every workflow meets the highest standards of accuracy and reliability for our clinical customers. You will act as the critical link between development and production, translating complex technical requirements into clear test cases and actionable feedback. You will own the creation and maintenance of all testing artifacts within our Quality Management System, providing full traceability from requirement to deployment. You will leverage AI tools to enhance manual testing processes and drive efficiency across the LIMS testing lifecycle. You will actively participate in code reviews to verify that implemented features align with intended behavior and regulatory expectations. You will respond promptly to operator issues reported during testing and collaborate with engineers to drive resolutions. You will help to build upon the strong technology and execution found at BillionToOne by safeguarding the integrity of our high-throughput prenatal diagnostics lab operations.

Key facts

What you'll do

• Assist in testing and documenting new LIMS workflow versions to validate functionality before production deployment.
• Assist in performing LIMS code reviews, verifications, and validations to catch issues early and ensure regulatory alignment.
• Handle QA documentation for the LIMS team and keep relevant parties accountable for compliance and traceability.
• Increase efficiency using AI tools and integration into manual processes to accelerate testing cycles and reduce human error.
• Ensure compliance to all relevant corporate and regulatory requirements governing laboratory informatics and clinical testing.
• Create, file, and track documents such as change requests and change notifications in our Quality Management System with precision.
• Support user acceptance testing for new LIMS features and workflows, gathering feedback from operators and stakeholders.
• Investigate and diagnose advanced technical issues within the LIMS environment, applying troubleshooting methodologies to identify root causes.
• Collaborate closely with developers, quality assurance leads, and laboratory operations to resolve issues and streamline testing activities.
• Maintain detailed test records, results, and evidence to support audits, inspections, and continuous improvement initiatives.
• Contribute to the refinement of testing standards and best practices across the LIMS team to strengthen overall quality.
• Act as a subject matter expert for LIMS testing processes, mentoring peers and new hires where appropriate.
• Participate in on-call or incident response activities as needed to address production issues and minimize patient impact.
• Champion data integrity and system reliability to ensure that our diagnostics platform supports critical clinical decisions.

Requirements

• Bachelor's degree with biological or computational focus to build a strong foundation for understanding laboratory workflows and data systems.
• Ability to troubleshoot and diagnose advanced technical issues to maintain system uptime and data integrity in a high-stakes environment.
• Familiarity with Python (able to read and understand code to diagnose errors from tracebacks) to effectively collaborate with engineering teams and interpret system logs.
• Prior experience configuring LIMS or similar customer-facing production software to ensure smooth implementation and adoption.
• Prior experience working in a research or production lab to understand real-world laboratory operations and user needs.
• Strong attention to detail and ability to work flexibly and well under given timeframes to meet strict testing deadlines and regulatory milestones.
• Highly organized, strong written and verbal communication skills to coordinate with cross-functional teams and document processes clearly.
• Enjoy a wide variety of daily tasks in a fast-paced, time-sensitive environment where priorities can shift based on clinical demands.
• Willingness to adhere to strict documentation standards and follow established procedures without deviation to maintain compliance.
• Commitment to working in a regulated environment where accuracy, reproducibility, and traceability are non negotiable.
• Readiness to engage in continuous learning to keep up with evolving laboratory technologies and testing methodologies.
• Ability to manage multiple testing activities simultaneously while maintaining a high standard of quality and accuracy.

Nice to have

• Experience working in Clinical Laboratory Improvement Amendments / College of American Pathologists CLIA / CAP Lab, or other regulated laboratory to understand compliance expectations and audit readiness.
• Experience with data analysis using Python, SQL, or Excel to support test data validation and operational reporting.
• Familiarity with Quality Management Systems and related regulations such as CFR 21 Part 11, ISO 13485, and other standards relevant to clinical diagnostics.

Practical notes

• For this position, the base pay rate is: $33 per hour.
• This role is based in Menlo Park, CA or Union City, CA.
• Engagement details are listed in the source information and should be reviewed for specific terms and scheduling expectations.