QA Specialist

About Our Client This organization operates in the field of cell‑free DNA testing, focusing on oncology, women’s health, and organ health. It addresses the challenge of integrating personalized genetic testing and diagnostics into standard medical care to enable earlier and more targeted health interventions, aiming to improve patient outcomes over time. The team comprises professionals from diverse disciplines including statistics, genetics, medicine, laboratory science, business, and software engineering, contributing to advancements in genetic disease management. About the Opportunity The QA Specialist is responsible for ensuring the safety, quality, and regulatory compliance of the facility’s operations, products, and vendors. This role supports the management of quality documentation, training programs, and quality system processes, directly impacting the organization’s ability to maintain high standards and meet compliance requirements. The position contributes to continuous quality improvement and regulatory adherence within the quality management system. Responsibilities Assist employees with recommendations on controlled documentation release, structuring, and changes Support creation and revision of documents and training plans across functional teams Manage release and control of updates to quality system and product documentation, ensuring data security Operate the electronic document management system to maintain current document revisions Collaborate with users to review and approve documents and records Participate in quality system‑related meetings as needed Collect and trend quality metrics under supervision Provide administrative support for quality management system processes such as document control, training, CAPAs, deviations, SCARs, complaints, and NCRs Stay updated on relevant regulations and guidance (FDA, ISO13485, CLIA, CAP) Support internal and external audits, including serving as an internal auditor or scribe Handle protected health information in compliance with privacy regulations Complete required training related to HIPAA/PHI, policies, procedures, and security Maintain current status on training requirements Pass post‑offer criminal background check Perform other duties as assigned and pursue professional development Requirements Associate’s Degree, certificate, B.A., B.S., or equivalent; work experience may substitute for education Minimum 2 years of experience in clinical laboratory or biotech industry preferred, or relevant combination of skills, education, and experience Pay Range and Compensation Package Remote USA salary range: $79,700 to $99,600 USD Actual compensation depends on factors including skills, experience, certifications, and location Benefits & Perks Comprehensive medical, dental, and vision insurance plans for employees and dependents Life and disability insurance Free genetic testing for employees and their immediate families Fertility care benefits Pregnancy and baby bonding leave 401(k) retirement plan Commuter benefits Employee referral program Equal Opportunity Statement Our client is an equal opportunity employer. They celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, or national origin. #J-18808-Ljbffr RemoteHunter