Quality Specialist II
About The Position
BioReference Laboratories is seeking a Medical Technologist, Quality Specialist to join its Quality Systems Department at its headquarters in Elmwood Park, New Jersey. This is an onsite position and requires domestic travel, up to 30%. Under the direction of the Quality Supervisor, the Quality Specialist plans and coordinates quality functions, including quality control, audits, method and instrument validations, proficiency survey programs, standard operating procedures, regulatory compliance, and laboratory performance improvement. The role provides technical and quality oversight, supports problem solving and process improvement, and helps ensure accurate test performance and adherence to quality goals and applicable regulatory requirements.
Requirements
- Bachelor of Science in Medical Technology.
- At least 4 years of CLIA laboratory or related experience working as a Medical Technologist, with bench experience in areas such as urinalysis, special coagulation, hematology, toxicology, serology, or chemistry.
- A Medical Lab Technician with 8 or more years of experience working as a generalist in a CLIA laboratory will also be considered.
- Ability to travel domestically up to 30%.
- Ability to lift up to 50 pounds and/or carry objects weighing up to 25 pounds; lifting, carrying, pushing, and pulling objects are required.
- Work involves sitting, standing, and/or walking for periods of up to four hours; contact with water, biohazardous body fluids, and hazardous chemicals; and close attention to detail and accuracy.
Nice To Haves
- ASCP or other national certification preferred.
- ASQ certification is a plus.
Responsibilities
- Provide technical and quality oversight for areas of responsibility and serve as a quality resource for problem solving and process improvement.
- Investigate and document non-conforming events, non-conforming products, and corrective and preventive actions (CAPAs); recommend monitors and improvements.
- Conduct on-site visits to remote laboratories at least annually or as directed by the Laboratory Director.
- Maintain documentation, conduct audits, and ensure corrective actions to support compliance with regulatory agency standards.
- Assist Laboratory Management with planning validation study proposals; initiate validation studies, troubleshoot during validation, and review experiments before submission where applicable.
- Support inspection readiness, including self-inspections, risk assessments, and workflow analyses; implement and ensure compliance with department and company policies and procedures.
- Review proficiency survey results and conduct corrective action investigations.
- Review inspection reports from State, CMS, CAP, and COLA agencies with appropriate personnel.
- Perform other responsibilities required by CLIA and other applicable local, state, or federal regulations.
- Perform other assignments or projects as specified by the Supervisor, Manager, or Director.
- Review, interpret, and maintain the Quality Control Program; arrange and conduct quality audits; assist with and review method and instrument validations; coordinate proficiency survey programs; and write and review standard operating procedures.
- Assist laboratories with performance improvement and quality management monitoring.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
