at Northwestern University in Evanston, Illinois, United States
Job Description
Job Opening Id: 54058
Department: MED-Transplant Center
Salary/Grade: NEX/15
Target hiring range for this position will be between be range is as be $31.31-$33.82 per hour. Offered salary will be determined by the applicant’s education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data.
Job Summary:
Under the general supervision of the clinical and research transplant laboratories’ leadership, the Laboratory Quality Specialist is responsible for supporting and maintaining all regulatory and accreditation standards (CLIA, ASHI, CAP, OPTN/UNOS) related to laboratory quality management. They will champion various aspects of the Quality Management Program, such as tracking and investigating non-conforming events, and facilitating their resolution with guidance of the laboratory leadership. The specialist will ensure compliance with regulatory requirements, monitor any potential changes to these requirements that may affect laboratory operations, and harmonize practices amongst all the transplant laboratory groups.
Specific Responsibilities:
Technical:
- The position will be responsible for providing QA leadership and support to the transplant laboratory and biorepository, ensuring quality and compliance procedures are followed across the laboratories in support of ASHI/CLIA and CAP accreditation and OPTN/UNOS regulatory compliance.
- Aids in planning and participates in preparedness activities in support of regulatory inspections.
- Regularly meets with the laboratory management team in the development of best practice standards, identifying potential training needs and optimization of resource utilization.
- Leads monthly Quality Assurance meetings, delegates monthly QA activities to team members.
- Identifies assay problems through observation, compilation, and trending of laboratory data, and recommends problem solving based on root cause analysis.
- Works closely with section supervisors (Flow, Molecular, Intake, and Biorepository) and helps coordinate Quality Assurance activities, including the preparation of QA reports and documentation.
- Collaborates in laboratory process validations.
- Tracks quality of laboratory instrumentation and reagents, assists section supervisors to ensure that preventative maintenance is scheduled and performed per regulations.
