Clinical Laboratory Quality Specialist I (FT, 40 Hours)
BioReference Laboratories

Elmwood Park, New Jersey

Posted in Manufacturing and Production

This job has expired.

Job Info

We are looking for a Clinical Laboratory Quality Specialist I in our Elmwood Park, NJ location.

Schedule: Monday-Friday 9:00am-5:30PM


Under the directive of the Quality Supervisor, the Quality Specialist I is responsible for planning and coordinating all of the functions within the scope of Quality. This includes but is not limited to reviewing, arranging for, and conducting internal quality audits, assisting with the Quality Specialist II reviewing of 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. Additional tasks can be assigned at the discretion of the Supervisor, Manager and/or Director.

Duties may include but are not necessarily limited to the following:

· Provides 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/or CAPAs as necessary.

· Monitors and ensures implementation of goals to meet established quality assurance, quality control, quality improvement plans and turnaround time.

· Ensures compliance with regulatory agency standards through maintaining proper documentation, conducting audits, and ensuring proper corrective actions.

· Assists the Laboratory in maintaining and updating all Standard Operating Procedures and Forms.

· Performs review of validations as applicable.

· Interacts with co-workers in a way that promotes a harmonious and cooperative working environment.

· Presents a professional appearance and manner and must be able to remain calm and professional, even under stressful conditions.

· May be required to adjust ones schedule, at the needs/demands of the company.

· Is involved in inspection readiness preparation and exercises including but not limited to: self- inspections, process improvement excises (i.e. risk assessments) and workflow analysis.

· Supports, implements, and ensures compliance with all department and company policies and procedures.

· Ensures that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently; and whenever necessary, identify needs for remedial training or continuing education to improve skills.

· Arranges and conducts internal quality audits

· Maintains compliance with all regulatory standards to recognize results or problems that require referral to the Quality Systems Supervisor/Manager/Director.

· Assists the Laboratory with performance improvement/quality management monitors.

· Effectively coordinates Quality Management meetings and prepares agendas and minutes using standardized formats.

· Maintains working knowledge of regulatory standards.

· Demonstrates knowledge of all departmental procedures.

· This position will support all BioReference Laboratories (15-20% travel if necessary).

· Performs other assignments or projects as specified by the Supervisor/Manager/Director.


· Minimum of a High School Diploma or equivalent with a minimum of 2 years' experience in a clinical laboratory environment.

· Medical Laboratory Technician, 2-year Associate's Degree, or certification in a life science preferred.

· Must have proven interpersonal, communication, computer aptitude in Microsoft suite skills

· This position will support all BioReference Laboratories (15-20% travel if necessary).


· 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.

"BioReference is an Equal Opportunity Employer"

This job has expired.

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