Quality Specialist II
About The Position
BioReference Laboratories is looking for a Medical Technologist, Quality Specialist to join our Quality Systems Department at our headquarters location in Elmwood Park, NJ. This is not a remote position. Travel Required. Under the directive of the Quality Supervisor, the Quality Specialist is responsible for planning and coordinating all of the functions within the scope of Quality. This includes but is not limited to 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, maintaining compliance with all regulatory standards to ensure that services are of the highest quality, recognizing results or problems, assisting the Laboratory with performance improvement/quality management monitors, and ensuring the laboratory is adhering to all regulatory requirements.
Requirements
- Bachelors 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.
Nice To Haves
- ASCP or other national certification preferred.
- ASQ Certification a plus.
Responsibilities
- 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.
- Assists 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 review of experiments prior to submission where applicable.
- Is involved in inspection readiness preparation and exercises including but not limited to: self-inspections, process improvement exercises (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 Clinical Laboratory Improvement Amendments (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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
