Quality Associate, Oncology Menlo Park, CA

Ready to redefine what's possible in molecular diagnostics?

Join a team of brilliant, passionate innovators who wake up every day determined to transform healthcare. At Billion To One , we've built something extraordinary—a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we strive to build products that are 10x better than anything that exists today.

Our people are our greatest asset:talented scientists, engineers, sales professionals, and visionaries united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion—every innovation you contribute helps remove fear of unknown from some of life's most critical medical moments. If you're driven by purpose, energized by innovation, and ready to help build the future of precision medicine, this is where you belong.

Billion To One  is looking for a Quality Associate to join our Northstar team and support our quality and continuous improvement initiatives in clinical operations. The ideal candidate will be expected to understand and apply principles of quality management practices to the Clinical Laboratory and supporting functions of Client Services, Engineering, Reagent Manufacturing, Supply Chain, etc. The Quality Associate is an on-site position and reports to the Quality Manager.

Responsibilities:

• Collaborate with cross-functional teams to develop and maintain standard operating procedures (SOPs) and work instructions through document lifecycle management.
• Review change status activities to ensure compliance with configuration management policies.
• Provide training and support to laboratory staff on quality assurance processes and procedures.
• Review and maintain facility, equipment lifecycle, patient, processing, and quality control records of the quality management system.
• Develop, implement, and maintain quality assurance programs and systems to ensure compliance with regulatory requirements (CLIA, CAP, NYSDOH, etc.) and industry best practices.
• Play a key role in the preparation of external audits and inspections by accreditation and regulatory agencies such as CLIA, CAP, NY, and county and state inspectors.
• Conduct internal audits and assessments to identify areas for improvement and implement corrective and preventive actions as needed.
• Ensure quality processes, initiatives, and issues of the clinical laboratory and other supporting laboratory operation functions are being addressed and raised in a proactive manner.
• Assist in the development and implementation of quality improvement projects and initiatives to enhance operational efficiency and effectiveness.
• Stay up-to-date with industry trends and regulatory changes to ensure compliance and best practices.

Requirements:

• Bachelor of Science in Medical Technology, Biology, Chemistry, or related field.
• Minimum of 1 year of relevant experience in a high-complexity CLIA, CAP, or NYS accredited or certified laboratory.
• Knowledge of regulatory requirements and quality management principles.
• High degree of initiative and self-motivation.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• Detailed-oriented with analytical and problem-solving skills
• Ability to successfully balance and manage multiple priorities in a fast-paced, deadline driven environment.
• Experience with ensuring and maintaining integrity and quality of the lab.

Nice-To-Haves:

• Ability to clearly communicate complex information to internal and external stakeholders
• Experience working in or with quality assurance for a CLIA or CAP laboratory.
• Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
• Open, transparent culture that includes weekly Town Hall meetings
• The ability to indirectly or directly change the lives of hundreds of thousands patients
• Multiple…