Company Description
THE MEDICAL HEART OF MARYLAND
Treating over 330,000 patients every year, the University of Maryland Medical Center is at the vital core of Maryland’s health care system and community. We’re known for our prestigious expertise in innovative research and education, along with the talented staff and advanced centers that make it all possible. The R Adams Cowley Shock Trauma Center, the world’s first center dedicated to trauma, treats more than 7,500 critically injured patients a year with an incredible 97 percent survival rate. We also have one of the nation’s largest kidney and pancreas transplant programs at The Joseph and Corinne Schwartz Division of Transplantation, home to Maryland’s first steroid-free protocol and pancreas/kidney transplant. From our National Cancer Institute-designated UM Marlene and Stewart Greenebaum Cancer Center to The University of Maryland’s Children’s Hospital, one of the largest pediatric centers in the state, we are dedicated to saving and transforming lives.
Job Description
Full time, M-F (8AM-4:30PM)
1. General Summary
Under general supervision of the Associate Director of Transplant and Cellular Therapy, with medical input from the Medical Director of the Cellular Therapy Lab, and the Facility Director, oversees and coordinates the quality assurance activities, requirements, licensure requirements and accreditation activities as well as develops quality programs of the Cellular Therapy Laboratory and Fannie Angelos Cellular Laboratory.
II. Principal Responsibilities and Tasks
The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all job duties performed by personnel so classified.
1. Supervise/develop the Quality Assurance of the Cellular Therapy and Fannie Angelos Cellular Laboratories to comply with all applicable regulatory and accreditation requirements including FDA, AABB, CLIA, CAP, TJC, FACT, and OSHA standards and requirements.
- 1. Manage quality assurance program.
- 2. Assure compliance with regulations.
2. Write, review, edit and validate standard operating procedures with laboratory leadership.
3. Represent the Laboratories for inspections by FDA, AABB, CAP, TJC, and FACT.
4. Develop and implement the performance and documentation of internal auditing.
5. Write, edit, perform and evaluate validation plans. Quality assurance specialist should manage program, document trends, assure follow-up, etc.
6. Develop, implement, document training and education program, equipment program, and safety program in conjunction with the lab leadership.
7. Reviews all occurrence reports with the lab and clinical leadership 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.
8. Develop self-inspection teams throughout the Laboratories to ensure and improve current practices, to keep up with and implement future practices.
9. Direct, plan or participate in laboratory staff orientation, training and competency evaluations.
Qualifications
Education and Experience
1. Baccalaureate degree from an accredited college in a relevant discipline required.
2. Four years of progressively responsible experience in a lab required.
3. Two years of Quality Assurance experience and preferred working knowledge of AABB, FDA, FACT, TJC, CLIA, and CAP, Transfusion Services, and Blood Donor Center are essential.
4. Certification as a medical technologist or equivalent preferred, or an equivalent combination of education and experience.
Knowledge, Skills and Abilities
1. Demonstrated verbal and written communication, organizational, interpersonal skills.
2. Demonstrates basic computer literacy and the ability to coordinate and complete multiple projects in an effective, timely manner.
3. Must be self-motivated and able to work independently.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Compensation
- Pay Range: $49.65-$60.68
- Other Compensation (if applicable):
Review the 2024-2025 UMMS Benefits Guide