Quality Associate, Oncology

Overview

Ready to redefine what's possible in molecular diagnostics? 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 understand and apply principles of quality management practices to the Clinical Laboratory and supporting functions of Client Services, Engineering, Reagent Manufacturing, Supply Chain, and more.

The Quality Associate is an on-site position and reports to the Quality Manager.

• 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 addressed proactively.
• 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.

• 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.
• Detail-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.

• 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 of patients.
• Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered up to 80%.
• Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%).
• Supplemental fertility benefits coverage.
• Retirement savings program including a 4% Company match.
• Increased paid time off with tenure.
• Latest hardware and lab equipment, on-site lunches, and campus perks (gym, restaurants).
• Free on-site EV charging (compatible with all EVs, including Tesla).

At Billion To One , we offer a total compensation package that includes base pay, equity options, and a corporate bonus program, on top of industry-leading benefits. For this position, the total compensation package is $107,153 per year, including a base pay range of $73,920-$84,480 per year.

Billion To One  is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Billion To One  is a next-generation molecular diagnostics company on a mission to make powerful, accurate diagnostic tests accessible to everyone. Our QCT molecular counting technology enhances disease detection resolution by over a thousandfold using cell-free DNA. Our impact includes Unity Complete and Northstar predictions in prenatal and cancer diagnostics, with growth and recognition across the industry.

Ready to help us change the world, one diagnosis at a time? Learn more at