Quality Specialist II

Job Description

This position is responsible for planning and coordinating all functions within the scope of Quality. This includes reviewing, interpreting, and maintaining the Quality Control Program, arranging for and conducting quality audits, assisting with and reviewing method/instrument validations, coordinating proficiency survey programs, writing and reviewing standard operating procedures, ensuring compliance with all regulatory standards, recognizing results or problems, assisting the laboratory with performance improvement/quality management monitors, and ensuring the laboratory adheres to all regulatory requirements.

Duties and Accountabilities

• Provides technical and quality oversight of area(s) of responsibility.
• Serves as a quality resource for problem solving and process improvement to ensure accurate test performance and meets all quality goals.
• Investigates and documents non-conforming events, non-conforming products, and CAPAs as necessary. Makes recommendations for monitors and improvements.
• Performs on-site visits of remote laboratories at least once per year or as defined by the Laboratory Director.
• Ensures compliance with regulatory agency standards through maintaining proper documentation, conducting audits, and ensuring proper corrective actions.
• Aids in the planning of validation study proposals, with Laboratory Management, prior to validating and implementing new methods and technologies, initiating validation studies, troubleshooting during the validation process, and reviewing experiments prior to submission where applicable.
• Is involved in inspection readiness preparation and exercises including but not limited to: self-inspections, process improvement excises (i.e. risk assessments) and workflow analyses.
• Supports, implements, and ensures compliance with all department and company policies and procedures.
• Reviews proficiency survey results and conducts corrective action investigations.
• May perform other responsibilities as mandated by CLIA and any other pertinent local, state, or federal regulations.
• Reviews inspection reports by regulatory agencies (State, CMS, CAP, and COLA) with the appropriate personnel as necessary.
• Performs other assignments or projects as specified by the Supervisor/Manager/Director.

Minimum Qualifications

• Bachelor's of Science in Medical Technology.
• 4 or more years of CLIA laboratory or related experience working as a Medical Technologist.
• Bench areas of experience: Urinalysis, Special Coagulation, Hematology, Toxicology, Serology, Chemistry, etc.
• Will consider a Medical Lab Technician with 8+ years of experience working as a generalist in a CLIA lab.
• ASCP or other national certification preferred.
• ASQ Certification a plus.

Physical Demands

• Work requires sitting, standing, and/or walking for periods of up to four hours.
• Work requires contact with water (hand washing and cleaning), biohazardous body fluids, and hazardous chemicals.
• Work is varied in nature with sufficient noise and interruptions to cause distraction and stress.
• Work requires close attention to detail and accuracy.

OSHA Risk Factor

• Category 1

Equal Opportunity Employer

BioReference Laboratories is an Equal Opportunity Employer.