Quality Assurance Specialist

University of Maryland Medical System•Baltimore, MD

8d•Onsite

About The Position

Under general supervision of the Director, Hospital Labs, with medical input from the Medical Director Laboratories of Pathology, Blood Bank Medical Director and other related Laboratories’ Director, oversees and coordinates the quality assurance activities, requirements, licensure requirements and accreditation activities as well as develops quality programs of the Laboratories of Pathology.

Requirements

Baccalaureate degree from an accredited college in a relevant discipline required.
Four years of progressively responsible experience in a lab required.
Two years of Quality Assurance experience.
Knowledge of biosafety and chemical hazard requirements and knowledge of writing technical procedures.
Ability to use a computerized system for logging and tracking laboratory test results and patient information for calibrating laboratory equipment.
Ability to use software for word-processing, spreadsheet, and database management.
Ability to perform mathematical and statistical operations for recording and evaluating laboratory results, including mean, standard deviation and coefficient of variation.
Ability to follow detailed written or oral instructions accurately.
Ability to operate laboratory equipment such as centrifuges, automated analyzers, microscopes or specialized laboratory equipment specific to the assigned laboratory.
Effective verbal and written communications skills are necessary in order to work with medical or nursing staff in order to resolve problems and concerns regarding specimens or laboratory tests.
Ability to properly record test results and record quality control statistics.
Ability to demonstrate knowledge and skills necessary to provide care appropriate to the patient population(s) served.
Ability to demonstrate knowledge of the principles of growth and development over the life span and ability to assess data reflective of the patient’s requirements relative to his or her age specific and population-specific needs.

Nice To Haves

Preferred working knowledge of AABB, FDA, FAHCT, TJC, CLIA, and CAP, Transfusion Services, and Blood Donor Center are essential.
Certification as a medical technologist or equivalent preferred, or an equivalent combination of education and experience is preferred.

Responsibilities

Supervise/develop the Quality Assurance of the Laboratories of Pathology to comply with all applicable regulatory and accreditation requirements including FDA, AABB, CLIA, CAP, TJC, FAHCT, and OSHA standards and requirements.
Manage quality assurance program.
Assure compliance with regulations.
Write, review, edit and validate standard operating procedures with Associate Administrator and Medical Director of the Laboratories of Pathology.
Represent the Laboratories of Pathology for inspections by FDA, AABB, CAP, TJC, and FAHCT.
Develop and implement the performance and documentation of internal auditing.
Write, edit, perform and evaluate validation plans. Quality assurance specialist should manage program, document trends, assure follow-up, etc.
Develop, implement, document training and education program, equipment program, and safety program in conjunction with the Assistant Directors, Hospital Labs.
Reviews all Laboratories of Pathology variance reports with the Associate Administrator & related Laboratory Director interacts with related departments such as Risk Management, Quality Improvement Committee, Infection Control, Facilities Management, Biomedical Engineering, Environmental Services, UMMS and UMAB Environmental Health and Safety Departments as required.
Develop self inspection teams throughout the Laboratories to ensure and improve current practices, to keep up with and implement future practices.
Direct, plan or participate in laboratory staff orientation, training and competency evaluations.