GENETWORx

Full Time Permanent

At GENETWORx Laboratory, we improve the health and wellness of lives around the world through dedicated research, experienced scientists, 21-st century technology, and in-depth diagnostics. Healthcare is personal and as such, the future needs to be, too. By intersecting genetic testing with personalized medicine and pharmacogenomics, we’re positioning our patients and empowering physicians with more precise, individualized, effective results.
As a leader in precision COVID-19 testing, GENETWORx provides unparalleled support, results, and clarity during these uncertain times. GENETWORx has armed healthcare providers, employers and universities with rapid and accurate COVID-19 diagnostic and antibody testing which is essential for reopening businesses and communities.

The Laboratory Quality Specialist is responsible for the oversight of the Quality elements in our Clinical Laboratory. The quality elements include but are not limited to developing, implementing, and maintaining a quality management system, ensuring (clinical) compliance with all regulatory requirements, facilitating feedback monitoring and resolution for customer satisfaction and nonconforming event management. The Laboratory Quality Specialist will champion specialized and focused aspects of the Laboratory Quality Management Program.

Responsibilities

• Continuously monitor policies/procedures to ensure the clinical laboratory meets respective standards and regulations; supports regulatory registrations, inspections, reporting, and formal communications with CLIA, CAP, FDA, and states with specific requirements such as NY and CA
• Assist in developing/maintaining clinical laboratory QA plans, policies, processes, and procedures in accordance with federal and state guidelines
• Support the Proficiency Testing program, policy development, and training
• Assist in developing clinical laboratory-based metrics to measure efficacy of the quality system and provides visibility for management oversight; ensure quality system robustness through internal audits/investigations, evaluations, process implementation, and continuous improvement opportunities
• Review/document nonconforming events, conduct investigations, perform root cause analysis, and develop corrective/preventive actions
• Provide assessment, quality input and guidance, investigational support, and resolution for end-user feedback
• Assist with project management for assignments, such as gap analysis, risk management, document control, audits, inspections, process creation and improvement as needed

Qualifications

• Associates Degree in Medical Laboratory Technology with 6 years of Laboratory experience OR
• Bachelor's degree in Medical Technology, biology, molecular biology, chemistry with 3 years of Laboratory experience
• 1+ years of quality management system/assurance experience a plus
• Demonstrated understanding of/experience working with FDA, CLIA, CAP, and HIPAA regulation
• Direct experience with audits or inspections by regulatory bodies such as CAP, NY, or FDA
• Direct experience working with process and project implementation, management, or improvement
• Demonstrated experience in a quality assurance role in a regulated, clinical environment desired