Description :
Education and Related Experience Requirements:
Bachelor of Science or Arts degree in a scientifically related discipline or in Clinical Laboratory Sciences or Medical Laboratory Technology, Supervisory experience is a plus in an animal and or human Clinical Pathology laboratory. Current certification by American Association of Clinical Pathologists is required (or eligible). Assay and Equipment Qualification and experience within a GLP Clinical Pathology Laboratory environment.
Basic Purpose and Objective:
Develops and executes Qualification plan, generates data report with EP evaluator, creates summary report, submits all documentation for signatures and to the QA auditing group. Transfers successfully qualified assays to department staff via SOP generation and training, ensures training records are updated. Assures client and company performance expectations are met. Performs Hematological, Biochemical, ELISA and RIA analyses for the assessment of health and toxicity effects in clinical and preclinical trials in accordance with Good Laboratory Practices and NCCLS .
Equipment Experience : (or similar systems)
Automation systems for Clinical Chemistry (Hitachi 917), Hematology (Advia 120), Coagulation (STA Compact), Urine Analysis (Clinitek 200), Serum Electrophoresis, RIA assays (Packard Cobra II Gamma counter and Immulite (DPC).
Job Responsibilities:
Ensures protocols with special testing requirements are met
Maintains vendor contact with regards to new assay developments and implementation
Maintains workload metrics for each testing discipline and personnel
Adheres to defined time tables for method qualification
Ensuring that the laboratory workflow is efficient and fluent
Assist with supervising and scheduling the daily activities of the technical staff.
Operate, maintain, and troubleshoot current Clinical Pathology analyzers and methodologies following Standard Operating Procedures (SOPs).
Understand and apply Good Laboratory practices (GLP), and non GLP regulations and other study requirements.
Work with analytical Informatics manager to assure equipment and software validation adheres to qualification Standard Operations Procedures..
Assists Manager with implementation of new procedures and writing of SOP’s.
Fulfill any other duties within competence and experience as required or assigned.
