Position SummaryReports to IVF division director and is responsible for the for the overall operation and administration of the Embryologylaboratory operation. It is the responsibility of the Embryology Laboratory Director (ELD) to ensure that all documentation and licensure requirements are met. All accredited laboratories must document an ongoing quality control (QC) program for each test and piece of equipment within the laboratory. The laboratory must also participate in a quality assurance program that includes continuous quality improvement (CQI) assessments and participation in proficiency testing for all laboratory testing procedures. The laboratory must maintain documentation of all activities that are conducted within the laboratory. These include current policy and procedure manuals as well as manuals or documentation of laboratory safety, infection control, disaster plans, Health Insurance Portability and Accountability Act (HIPAA) procedures, chemical hygiene, and laboratory personnel. In addition, laboratories must employ and maintain a system that provides proper patient preparation and identification; proper patient specimen collection, preservation, transportation, and processing; and accurate reporting of laboratory test and procedural results. Laboratory directors should have an intimate knowledge of all procedures performed in these laboratories and be available to provide consultation when required.The ELD may perform the duties of the technical supervisor general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications.The laboratory director should have expertise and/or specialized training in biochemistry, cell biology, and physiology of reproduction, with experience in experimental design, statistical analysis, and laboratory problem solving. The director should be responsible for formulating the policies and protocols and communicating with the medical director all information concerning patient progress and protocols. Embryology laboratory procedures include:Culture media preparation and laboratory QCOocyte isolation and identificationOocyte maturity and health status assessmentOocyte inseminationEvaluation of fertilizationZygote quality assessmentEmbryo culture and gradingEmbryo transferGamete or embryo cryopreservationMicromanipulation of gametes and/or embryos, including intracytoplasmic sperm injection, assisted hatching, and embryo biopsy.Essential Duties and Responsibilities:In order to succeed in this role successfully, an individual must be able to perform each essential duty satisfactorily. Other duties may be assigned.Responsible for the development, implementation and maintenance of a Quality Management ProgramEnsures that proficiency testing, alternative assessment, and QC procedures are sufficient for the extent of procedures performed in the laboratory.Ensures that the performance specifications for new tests, instruments, and methods introduced to the laboratory have been properly validated or verified prior to being used for patient testing.Ensures provision of educational programs, strategic planning, and research and development appropriate to the needs of the laboratory and institution.Ensures sufficient numbers of personnel with appropriate educational qualifications, documented training and experience, and adequatecompetency to meet the needs of the laboratory.Interacts with government and other agencies as appropriate.Directly involved in the selection of all laboratory equipment, supplies, and services with respect to quality.Ensures that the physical plant and environmental conditions of thelaboratoryare appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards.Ensures that all necessary remedial actions are taken and documented whenever significant deviations from thelaboratory's establishedperformance characteristicsare identified, and thatpatienttest results are reported only when the system is functioning properly.QualificationsEducationPhD and HCLD /ELD certification required.Bachelor's in chemical, physical, or biological science or medical technology from anaccredited institution would be consideredMust hold a current Embryology Laboratory Director certification by the American Board of Bioanalysis.ExperienceA minimum of 4 years ofexperience on human specimens directing or supervising embryology testing in an embryology laboratory prior to 1992.Experience must include 60 personally performed, completed assisted reproductive procedures in humans administered under current standards of care. Procedures include:60 oocyte isolation from follicular aspirations60 sperm preparations60 intracytoplasmic sperm injections cycles60 documentation of fertilization60 preparation of embryos for embryo transfer60 cryopreservation procedures of oocyte/embryos