Under minimal supervision of the Serological Analysis Group Manager, assists in planning and administrating the activities in the HIV/STD Serology Team. Serves as Team Leader and oversees the performance of highly specialized immunological and serological techniques for the presence of antibodies or antigens by ensuring standard protocols and proper quality controls are followed for all the tests performed in the lab.
Ensures the technical staff are trained both in their primary assignment and cross-trained to assist as needed. Reviews outgoing reports for accuracy and timeliness; identifies unusual patterns and documents a corrective action plan. Evaluates the quality of reagents and manages material resources.
Consults with customers regarding test applications and interpretations. Assists in staff development by participating in team building strategies. Acts as a resource in matters of immunological/serological techniques and interpretation.
Coordinates Team's leave schedules. Develops and evaluates new techniques and presents project updates to the Group Manager for implementation. Duties are performed with considerable latitude for the use of scientific knowledge, initiative, and independent judgment. Essential Job Functions:
Attends work on a regular basis and predictable schedule in accordance with agency leave policy and performs other duties as assigned.
EJF 1. Under the direction of the Group Manager, serves as the laboratory's Team Leader. Plans and oversees the performance of highly specialized immunological and serological techniques for the presence of antibodies against or antigens from infectious microorganisms. Prioritizes work and makes assignments so that quality results are reported to customers without interruption. Reviews and validates data interpreted by technicians in the area. Analyzes specimen and test data to identify unusual patterns of either specimen submission or test results. Orders additional testing as needed. Works with vendors on instrumentation or test issues. Participates in the interview and selection process as needed. Assists the Group Manager in modeling a "service attitude" that is evident to those being served. Participates in the weekend and holiday rotations as needed. Based on the work area, consistently complies with DSHS Laboratory, local, state and federal guidelines to ensure a safe functioning laboratory. (35%)
EJF 2. Assists in the development and maintenance of a comprehensive quality assurance program for all tests performed in the Serological Analysis laboratory. Develops and updates Standard Operating Procedures (SOP's) following manufacturer's guidelines for all the tests performed in the laboratory as needed. Oversees the quality control of reagents/kits used in the HIV/STD Serology laboratory as required by CAP/CLIA. Oversees the preparation of QC materials, standards and reference materials following CAP/CLIA guidelines. Investigates quality assurance problems and presents findings to Group Manager. Proactively initiates or assists root cause investigations for corrective actions (CARs). Prepares corrective/preventive action requests (CAR / PAR) and other reports including data summaries as needed. Assists with implementation of corrective actions/laboratory improvements. Ensures corrective actions are completed. Ensures laboratory-wide preventative and routine maintenance is completed and documented in a timely fashion. Ensures quality control documentation for reagents is completed in a timely fashion. Ensures staff training and competency documentation is completed and maintained. (20%)
EJF 3. Oversees efforts to maintaining an organized, orderly, and timely inventory of laboratory reagents, supplies, and specimen archives. Orders reagents and supplies or communicates the need for orders to the Group Manager as needed. Maintains records regarding contracts and purchase orders. Using careful attention to detail and procedure, prepares requisitions and purchase orders for area resources. (15%)
EJF 4. Provides consultation and services to customers regarding specimen requirements, test results and interpretation, and other matters regarding HIV/STD serology, being capable of answering questions regarding laboratory analyses and test results interpretation. Provides data and/or reports to the Group Manager or other customers. (10%)
EJF 5. Researches new procedures independently and reports on their usefulness, determines the appropriate specifications for diagnostic reagents and equipment and presents to the Group Manager for implementation. Assists with the development of validation/verification studies for reagents/kits or new procedures and products. Evaluates the usefulness of new tests as directed by the Group Manager through gathering and analyzing verification/validation study data and authoring summaries. Implements the validation/verification process in all areas of testing as required by CAP/CLIA. (10%)
EJF 6. Performs other duties as assigned by the Group Manager including administrative functions as they relate to the Team. Other duties as assigned include but are not limited to actively participating and/or serving in a supporting role to meet the agency's obligations for disaster response and/or recovery or continuity of operations (COOP) activation. Such participation may require an alternate shift pattern assignment and/or location. (10%)
Knowledge Skills Abilities:
List the knowledge, skills, and abilities critical to performance in this position:
Knowledge of microbiology and immunology, including understanding of principles of enzyme immunoassay (ELISA), nucleic acid amplification assays, multiplex flow immunoassay using BioPlex 2200 system, Western blot (WB), Rapid plasma reagin (RPR) card test, and particle agglutination inhibition for Treponema pallidum (TP-PA).
Basic knowledge of management principles.
Ability to interpret written protocols following manufacturer's guidelines and update as needed.
Ability to detect malfunctions in test protocols and errors in transcribed results.
Ability to maintain positive customer relations.
Knowledge of quality assessment, quality control, and CAP/CLIA regulations in a laboratory and experience in evaluating data, interpreting test results, and taking corrective actions if needed.
Knowledge of validation/verification process of kits/reagents as required by CAP/CLIA.
Knowledge of budgetary and material management procedures.
Ability to interact with a team effectively, planning and prioritizing assignments, establishing goals for the work teams, and monitoring progress of teams.
Knowledge of basic laboratory safety and handling of blood borne pathogens.
Ability to teach serological / immunological concepts and procedures; use of various items of laboratory equipment; communicate technical instructions and interact effectively with staff.
Ability to work independently and make technical decisions based on professional knowledge and experience.
Skills in the use of computer and software applications for word processing, spreadsheet and database analysis, and results reporting.
Knowledge of statistics and their application to biological data.
Ability to review and make recommendations based on study data.
Ability to communicate effectively, both verbally and in writing, and follow verbal and written instructions, including SOP's.
Ability to conduct personnel interviews and evaluations.
Skill in manipulating standard laboratory equipment, including automated equipment for specimen processing with speed, accuracy, and safety.
List the licensure, certification, or registration required to perform this job:
Have an earned bachelor's, master's, or doctoral degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; or
Experience and education may be substituted as defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) Standards.
Must possess a valid Class C Texas driver's license, or equivalent license from another state.
Initial Selection Criteria:
Education: as required under Registration and Licensure Requirements.
Experience (Preferred but not required):
Experience monitoring and supervising in a laboratory setting.
Comprehensive knowledge of microbiology and immunology principles and techniques.
Experience with clinical laboratory testing, including procedures such as enzyme immunoassays (EIA or ELISA), nucleic acid amplification assays, immunofluorescent antibody (IFA) testing, and agglutination assays.
Knowledge of quality assurance, quality control, and CAP/CLIA regulations in a laboratory.
Hepatitis Risk High. Required Hepatitis B immunization is provided. Must wear provided personal protective equipment (including: face shield, gloves, laboratory coat, safety glasses) as required by testing/ safety procedures.
Interviews scheduled after screening.
Work hours/days and laboratory assignments may vary, staff members may be required to work on Saturday as part of a rotating schedule.
67B, 71A, 230X, 43TX
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Texas Health & Human Services Commission