Quality Specialist II

BioReference; Elmwood Park (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

BioReference Laboratories seeks a Medical Technologist, Quality Specialist to join the Quality Systems Department at our Elmwood Park, NJ headquarters. This role reviews the Quality Control Program, conducts audits, and writes SOPs to ensure regulatory compliance.

Requirements include a BS in Medical Technology and 4+ years in a CLIA laboratory; ASCP certification preferred. Up to 30% travel domestically. This is not a remote position.

Qualifications

• BS in Medical Technology or equivalent required.
• 4+ years in a CLIA laboratory as a Medical Technologist or related role.
• ASCP certification preferred.

Responsibilities

• Provides technical and quality oversight of areas of responsibility.
• Investigates non-conforming events and CAPAs as needed.
• Maintains documentation and conducts quality audits.
• Reviews SOPs, validations, and proficiency surveys.
• Ensures compliance with CLIA and other regulatory requirements.
• Participates in inspection readiness and process improvements.
• Supports corrective actions and performance improvement initiatives.
• Performs other duties as required by supervision.

Skills

Quality oversight

Audits

CAPA

Documentation

Regulatory compliance

Education

Bachelor's degree in Medical Technology

Job description

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.

Schedule

JOB DESCRIPTION

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 Laboratory with performance improvement/quality management monitors, and ensuring the laboratory is adhering 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.
• 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 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 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.

Minimum Qualifications

• 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.
• ASCP or other national certification preferred. ASQ Certification a plus.
• Up to 30% Domestic Travel

Physical Demands

• Medium work of lifting up to 50 pounds and/or carrying objects weighing up to 25 pounds.
• Responsible for lifting, carrying, pushing, and pulling objects.

Working Conditions

• 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

BioReference Laboratories is an Equal Opportunity Employer.