Quality Assurance Specialist

The University of Maryland Medical System (UMMS) is a 14-hospital system offering academic, community, and specialty medical services across Maryland and beyond. As a national and regional referral center, UMMS provides trauma, cancer care, neurocare, cardiac care, women’s and children’s health, and physical rehabilitation services. UMMS is the fourth largest private employer in the Baltimore metropolitan area and one of the top 20 employers in Maryland, offering clinical variety, professional growth, and robust support.

About the Role

Under the general supervision of the Director of Hospital Labs and with medical input from the Medical Director of Laboratories of Pathology, Blood Bank Medical Director, and other related laboratory directors, this role oversees and coordinates quality assurance activities, regulatory compliance, licensure, and accreditation for the Laboratories of Pathology. The position develops and implements quality programs to ensure adherence to applicable standards.

Responsibilities

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

Requirements

• Baccalaureate degree from an accredited college in a relevant discipline.
• Four years of progressively responsible experience in a laboratory setting.
• Two years of Quality Assurance experience, with preferred working knowledge of AABB, FDA, FAHCT, TJC, CLIA, CAP, Transfusion Services, and Blood Donor Center.
• Certification as a medical technologist or equivalent preferred, or an equivalent combination of education and experience.

Skills

• Knowledge of biosafety and chemical hazard requirements, as well as writing technical procedures.
• Ability to use computerized systems for logging and tracking laboratory test results, patient information, and equipment calibration.
• Proficiency in word-processing, spreadsheet, and database management software.
• 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.
• Experience operating laboratory equipment such as centrifuges, automated analyzers, microscopes, or specialized laboratory equipment.
• Effective verbal and written communication skills for collaborating with medical and nursing staff to resolve specimen or test-related issues.
• Ability to properly record test results and quality control statistics.
• Demonstrated knowledge and skills to provide care appropriate to the patient population(s) served, including principles of growth and development over the life span.
• Ability to assess data reflective of patient requirements relative to age-specific and population-specific needs.