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About the role
Key responsibilities & impact- Design, develop, and execute test cases based on software requirements, functional specifications, and user needs for laboratory systems.
- Perform manual and/or automated testing to validate software functionality, data integrity, and workflow performance in a CLIA-regulated environment.
- Partner closely with laboratory operations teams to understand end-to-end workflows and translate them into effective test scenarios.
- Identify, document, and track software defects; collaborate with engineering teams to troubleshoot and resolve issues.
- Support validation and verification activities for new software releases, system upgrades, and process changes in accordance with CLIA, CAP, NYSDOH, and internal quality standards.
- Ensure traceability between requirements, test cases, and validation documentation.
- Participate in risk assessments and impact analyses related to software changes affecting laboratory operations.
- Contribute to the development and continuous improvement of software testing strategies, SOPs, and documentation practices.
- Support audits and inspections by maintaining clear, thorough, and compliant testing documentation.
- Act as a quality advocate, ensuring software supports accurate, reliable, and timely patient testing results.
- Partner with Operational Excellence to align test strategies with process design, workflow optimization, and scalability initiatives.
- Provide input into system requirements and user stories based on laboratory workflow expertise and testing insights.
- Support critical feedback loops to ensure continuous improvements to software systems.
- Support change management efforts by assessing downstream operational impact of software releases and enhancements.
Requirements
What you’ll need- Bachelor’s degree in a scientific discipline (e.g., Biology, Molecular Biology, Bioinformatics) or related field, or equivalent experience.
- 2+ years of experience in software testing, quality assurance, or validation, preferably in a regulated environment.
- Familiarity with NGS workflows and/or clinical laboratory operations (CLIA, CAP, or equivalent).
- Experience writing and executing test cases based on requirements and specifications.
- Strong attention to detail and ability to identify edge cases and failure modes.
- Excellent documentation skills with a focus on clarity, completeness, and compliance.
- Demonstrated ability to translate complex operational workflows into structured test scenarios and validation strategies.
Benefits
Comp & perks- Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
- Free testing for employees and immediate families.
- Fertility care benefits.
- Pregnancy and baby bonding leave.
- 401k benefits.
- Commuter benefits.
- Generous employee referral program.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
software testingquality assurancevalidationtest case developmentautomated testingmanual testingdata integrity validationworkflow performance testingrisk assessmentimpact analysis
Soft Skills
attention to detaildocumentation skillscollaborationproblem-solvingcommunicationanalytical thinkingquality advocacycontinuous improvementprocess design alignmentuser story development