Job Description

JOB SUMMARY

The Quality Assurance Manager will be responsible for ensuring effective quality control, document control using MediaLab as primary platform, and quality assurance practices are in place, in conjunction with the Laboratory Director. This position will also be responsible for adherence to the Quality Management System and continuous improvement initiatives for QC operations and communicating relevant recommendations to Laboratory Manager and staff. The Manager will schedule monthly QA meetings with appropriate individuals, create the agenda, and provide relevant documents and data for review by the Laboratory Director at the meeting.  After the monthly QA meeting, the QA Manager will assemble and publish minutes and action items to appropriate individuals and departments.  The monthly QA meeting minutes and action items will be stored in MediaLab.

RESPONSIBILITIES

• Leads the QA/QC functions to ensure results, processes and systems meet required quality standards.
• Enforce and maintain document control procedures
• Overseeing that all aspects of company operations comply with CLIA, CAP, OSHA, FDA and other regulatory agencies requirements and current industry practices.
• Strengthening quality culture of the organization, coaching employees on investigation, root cause analysis, CAPA (corrective action plans) implementation, and risk management.
• Represents company during CLIA, CAP, OSHA, in-house visit, as well as other agency contacts as appropriate.
• Analyze, develop, implement and audit policies and procedures for applicability and compliance to regulations.
• Assist in the development, revision, and implementation of Standard Operating Procedures for the laboratory pertaining to safety, work hazards, and equipment.
• Responsible for laboratory's quality system procedures for executing how the company handles process validation, process control and enhancements, quality metric reporting, supplier qualification, design assurance programs, complaint handling and CAPA programs.
• Monitor, Inspect, train and complete reports on all quality related activities of products to and from staff.
• Perform, document, and track inspections.
• Evaluates company compliance with federal and safety regulations to reduce accidents and workplace injuries.
• Maintain proficiency testing events and evaluations.
• Guide and mentor staff regarding compliance initiatives and procedures.
• Works cross-functionally within company and with external partners.
• Participate in the development of information databases to support quality system infrastructure.
• Evaluate quality data, prepare monthly reports to monitor trends, and report to management to ensure the Company's continuous improvement efforts are on track.
• Review and approve reports and other documentation prepared by QA and QC for regulatory submissions/ inspections.
• Participate in risk analysis to identify appropriate protective measures to mitigate risk associated with identified hazards.
• Schedules monthly QA meetings and assembles minutes and action items and sends to appropriate individuals and departments.
• Places QA monthly meeting documents in MediaLab.

WORKING CONDITIONS

• This position requires frequent standing, sitting, bending, reaching, grasping, sitting and occasional climbing and crawling.
• May be exposed to noise, dirt, dust, fumes, loud noises, and blood borne pathogens.

PHYSICAL REQUIREMENTS

• Must be able to work under stress and in fast-paced environment. 
• Must be able to operate standard office machines, computers, telephones, etc. 
• Visual requirements:  Must be able to make visual color determinations, requires constant reading and close-up work. 
• Hearing/talking requirements:  Must be able to hear normal speech and faint sounds; must be able to communicate via telephone.   
• Must be able to lift 20 pounds.

JOB REQUIREMENTS

• Minimum two years of experience in a high complexity medical laboratory
• Minimum two years of experience as a Medical Technologist
• Holds an active license as a Clinical Laboratory Scientist in the State of Louisiana (State of Florida is a plus)

B0Pm2wQZO7