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QA SpecialistRemoteHunter • New York, New York, United States
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QA Specialist

RemoteHunter
  • US
    New York, New York, United States
  • US
    New York, New York, United States
Jetzt Bewerben

Über

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.
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  • New York, New York, United States

Sprachkenntnisse

  • English
Hinweis für Nutzer

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