Quality Systems Coordinator
An exciting opportunity is available for a seasoned Quality Systems Coordinator with hands on experience working in CLIA and CAP Lab along with QA experience. We are looking for a self-starting, highly organized individual who can work with diverse internal partners. Familiarity with CLIA/CAP/NYS standards, clinical genetics, and/or DNA analysis would be strong advantages.
GeneDx is a rapidly growing CLIA-Certified diagnostic genetics laboratory. We provide cutting edge technologies for genetic molecular diagnostics and offer vital, new-platform products in the critical area of molecular diagnostics. We specialize in genetic testing for rare hereditary disorders, but also test for common disorders. Our primary mission is to make clinical testing available to people with rare genetic conditions and their families.
The Coordinator will join a growing Quality Systems team with responsibility for assisting the QA/QC staff in each laboratory section. Duties include:
• Works directly with the technical staff in all departments on a daily basis to implement QC, QA and QI practices consistent with company policies and regulatory standards.
• Provides accurate advice, problem-solving, and coaching to the technical staff, promoted by a high level of accessibility and physical proximity.
• Performs self-inspections of all sections at least twice per year using CAP criteria, prepares deficiency reports, and helps set improvement goals as needed.
• Assists the QS team to conduct or request a wide range of audits related to quality and safety, scheduled throughout the year.
• Assists the QS team to produce SOPs and functional forms that are accurate and compliant with policies and regulations.
• Ensures that Quality System operations are efficient, effective and on time from both a compliance and business perspective.
• Conducts safety training and other presentations on a rotational basis with other team members.
• Assists in the preparation of materials for inspections, site visits, and license renewals.