Position Overview: The Laboratory Quality Specialist is responsible for the oversight of the Quality elements in a Clinical laboratory. The quality elements include but are not limited to developing, implementing, and maintaining a quality management system, ensuring compliance with all regulatory requirements, facilitating feedback monitoring and resolution for customer satisfaction and non-conforming event management. The Laboratory Quality Specialist will champion specialized and focused aspects of the Laboratory Quality Management Program.
- Continuously monitors policies and 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.
- Dedicated to specific aspects of the Quality System. Assists in developing and maintaining clinical laboratory QA plans, policies, processes, and procedures in accordance with federal and state guidelines, and supports the Proficiency Testing program, policy development, and training.
- Assists in developing laboratory-based metrics to measure efficacy of the quality system and provides visibility for management oversight; ensures quality system robustness through internal audits/investigations, evaluations, process implementation, and continuous improvement opportunities.
- Reviews and documents nonconforming events, conducts investigations, performs root cause analysis, and development of corrective and preventive actions.
- Provides assessment, quality input and guidance, investigational support, and resolution for end-user feedback; coordinates processes, reports and documentation for escalations arising from feedback.
- Assists with project management for assignments, such as gap analysis, risk management, document control, audits, inspections, process creation and improvement as needed.
- Exceptional written and verbal communication skills with strong attention to detail, organization, and record-keeping skills.
- Ability to collaborate across functions and with both internal and external stakeholders.
- Strong decision-making skills: ability to communicate ideas, opinions and counter arguments in a proactive and professional manner.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Assist with other duties as assigned.
Education and Experience
- Bachelor’s degree in Medical Technology, biology, molecular biology, chemistry with 3 years of Laboratory experience
- 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 environment desired.
Work Environment: May work in a variety of laboratory environments at Biosafety Levels I or II. They spend much of their time on their feet, actively working with patient samples on complex equipment.
Physical Demands: While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands to finger, handle or feel objects, tools or controls. The employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move objects up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision and the ability to adjust focus.
Travel: Work related travel will be minimal.