Quality Associate

Do you want to join one of the fastest-growing molecular diagnostics startups and develop products that can affect the lives of millions?

BillionToOne, ranked at the top 5% of Y Combinator companies with $250M+ in funding from prominent VC firms, has developed a DNA molecular counter that increases cfDNA diagnostic resolution by over 1,000 fold. BillionToOne's first product, UNITY™ is the first and only non-invasive prenatal test that can directly screen an unborn baby's risk for common and severe recessive gene disorders and chromosomal abnormalities, as well as fetal sex and fetal antigens, from a single tube of blood from the pregnant mother without paternal testing.

Responsibilities:

• Support clinical laboratory related issues and laboratory operations.
• Ensure that training and competency for the clinical laboratory is maintained
• Maintenance of equipment lifecycle, patient, processing, and facility records, and document control system.
• Plays key role in supporting preparation and onsite support during site surveys and audits by regulatory agencies.
• Support other routine Quality processes such as document control, employee training, investigations, equipment qualifications, internal audits, as required and directed by Manager.
• Ensure that all policies, procedures, and records are reviewed and approved.
• Execute special projects as assigned by Manager.
• Report and document all concern of test quality and/or safety to the Manager or Safety Officer, as applicable.
• Conduct routine laboratory walk-throughs/ quality inspections

Requirements:

• Bachelor of Science in a biological or life science
• 1+ years of relevant lab experience in a Clinical Laboratory Improvement Amendments(CLIA)/College of American Pathologists (CAP)/NYS accredited or certified lab.
• High degree of initiative and self-motivation.
• Experience interpreting and applying laboratory safety protocols.
• Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
• Ability to identify, analyze and solve problems with minimal direction and escalate concerns to manager.

Nice-To-Haves:

• Ability to clearly communicate complex technical information to internal and external stakeholders Experience with ensuring and maintaining integrity and quality of the lab.
• Experience with a Laboratory Information Management Systems (LIMS).
• Experience working in the quality department for a CAP/CLIA laboratory.

Benefits and Perks

• Competitive pay
• Generous equity package
• Suite of benefit plans; employee premiums paid 90% of Gold PPO plan
• Extremely generous Medical, Pregnancy, Parental and Family Leaves
• Retirement savings program with 4% Company matching
• Free daily on-site lunches provided from top eateries
• Latest and greatest hardware (laptop, lab equipment, facilities)
• A variety of perks on campus (state of the art gym, restaurant)
• Free on-site EV charging (compatible with all EVs, including Tesla)
• Working with a team of ‘rockstars’ who bring out the best in everyone
• The ability to indirectly or directly change the lives of hundreds of thousand patients
• Open, transparent culture that includes weekly Town Hall meetings

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

For this position, the base pay range is: $70,000-$90,000 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.