Quality Associate, BillionToOne

• 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

Desirable

• 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
• 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, 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