Quality Associate

BillionToOne is looking for a Quality Associate to join our Prenatal/UNITY 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. TheQuality 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, safety, equipment lifecycle, personnel, patient, processing, reagent 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

Qualifications:

• 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

Benefits And Perks:

• 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 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
• Increase paid time off with increased tenure
• Latest and greatest hardware (laptop, lab equipment, facilities)
• Daily on-site lunches provided from top eateries
• A variety of perks on campus (state of the art gym, restaurant)
• Free on-site EV charging (compatible with all EVs, including Tesla)

At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based on experience and salary/equity options split that the candidate chooses), (2) generous equity options offering, (3) corporate bonus program, on top of (4) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave, etc.).

For this position, we offer a total compensation package of $107,153per year, including a base pay range of $73,920 - $84,480 per year.

BillionToOne 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.