Address
Form of workThe Histocompatibility (HLA) Lab Technical Specialist is a key resource in the HLA lab. The individual in this position reports to the HLA lab Technical Director and is responsible for compliance, quality assurance and performance improvement, and assists in ensuring optimal laboratory operations. In addition, this individual is very involved in the implementation of new tests.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Quality and Safety
Manage regulatory compliance.
Monitor lab performance/regulatory compliance/final review of daily, weekly, monthly, annual surveillance documents.
Proposes remedial action plans and works with supervisor, technical director, lab director and/or division leadership to correct any failures.
Manage laboratory accreditation.
Submit annual accreditation application to ASHI.
Report regulatory deficiencies to technical director and director.
Prepare lab and lab staff for inspections.
Work with inspector during inspections.
Manage lab QA and safety programs.
Coordinate and document competency assessments.
Ensure that staff undergo appropriate competency assessments in a timely manner.
Create and update competency assessments as needed.
Plan and/or provide HLA specific continuing education for staff; ensure compliance with annual requirements.
Maintains a safe work environment for employees by establishing and enforcing all relevant safety procedures.
Human Resources
Coordinate, document, and assist with training of new staff and of existing staff on new methods.
Assist technical director with interviews and recommend candidates for hiring.
Technical and Operations
Coordinate sample workflows in the lab on a day-to-day basis to ensure that all samples are received, accessioned, and ordered appropriately in the LIS.
Manage laboratory quality control systems; assist in the development of the QC system and review systems, procedures, and reporting mechanisms for quality control of reagents, equipment, and test procedures.
Manages lab equipment according to department policy including maintenance and service.
Perform periodic review of QC data with lab Director, technical director, and technical staff.
Ensure all sections of the Quality Plan continue to be followed and update as necessary including dashboard quality metrics.
Coordinate proficiency testing, order surveys, enter test results, summarize PT reports for director review, investigate PT deficiencies, and present PT summaries to lab staff.
Manage controlled document creation and updates with the input of the lab director, technical director, and/or senior technologist.
Coordinate and monitor technical performance improvement reviews and conduct specific studies.
Work with HLA director and technical director on performance improvement initiatives and long-term goals.
Investigate, develop, and plan validation for new procedures, methods, products, and instruments.
Evaluate and provide input into selection of new equipment and software.
Identifies problematic or inefficient workflows and proposes solutions. Implements change as approved or directed.
Complete monthly surveillance according to lab procedure including proficiency testing, and QC.
Determines priority of work and provides input for prioritizing process improvement projects.
Clinical
Review and report of test results as appropriate.
Communicate and coordinate with clinical teams about testing status and sample needs.
Perform bench work less than 20% of the time.
On call responsibility that may include additional work in the overnight hours.
Financial
Inventory Management of supplies and reagents.
Manage equipment inventory including inventory, replacement, PM scheduling, and maintenance.
Meetings
Attend weekly Senior HLA staff meeting and consensus conference.
Attend biweekly lab staff meeting; conduct meeting in the absence of the technical director.
Attend transplant-related weekly meetings, as needed.
Attend Pathology operations meetings in the absence of the technical director.
Other
Teach medical technologist students, transplant coordinators, others as appropriate.
Attend seminars and conferences when possible and review current literature in the field to ensure personal professional growth.
Education and Experience:
Bachelor's degree in biological or chemical science or medical technology or clinical laboratory science
Certified Histocompatibility Specialist (CHS) certification required (ACHI)
Minimum of six years progressively responsible experience in a Histocompatibility (HLA) testing environment (at least 1-3 years in a lead/supervisory role is preferred).
Preferred:
Two or more years of prior experience in a supervisory capacity or in a project management or quality role in a histocompatibility testing setting.
At least 1-3 years in a lead/supervisory role.
Demonstrated knowledge in all areas of a histocompatibility laboratory accredited for solid organ and bone marrow transplantation.
Competence with antibody screening and analysis.
PCR-based typing experience (rSSO, SSP, SBT, or NGS).
Troubleshooting experience with assays and equipment.
Demonstrated knowledge of flow cytometry equipment, assays, and analysis.
