Technical Support Specialist
The Technical Support Specialist will be assigned to projects working in collaboration with management and California licensed personnel in the Laboratory Operations Department and the Research and Development personnel in the Product Development Department. This position will be responsible for the development, troubleshooting, and reworking assays that are being performed in Laboratory Operations. For pharmaceutical clients, the Technical Support Specialist will be developing new assays in collaboration with the Pharmaceutical companies. The incumbent must be knowledgeable of all current instrumentation, techniques involving DNA/RNA extractions, PCR and RT-PCR reactions, and DNA sequencing (i.e., Sanger Method, Next-Generation). Responsible for compliance to all applicable regulations including but not limited to the Food and Drug Administration, ISO and state and federal requirements.
- Works under the direction of the Director, Laboratory Operations on the development and implementation of overall objectives of projects.
- Develops, plans and guides the work of project members advising them on the more difficult and problematic areas related to production.
- Compiles QC data for commercial assays performed in the clinical lab with the oversight of the Director, Laboratory Operations Manager, Sr. Vice President, Laboratory Operations and Quality Systems.
- Works with the Director, Laboratory Operations in the collection and monitoring of QC trends for the performance of commercial assays performed in the clinical lab.
- Works with the Director, Laboratory Operations in the monitoring of inventory of critical consumables
- Contributes original/innovative ideas resulting in the improvement of the methodology of an assay to increase the efficiency of the performance of the assay during production.
- Exercises independent judgment and discretion, initiative and resourcefulness in making non-technical decisions.
- Performs, when necessary, all aspects of laboratory procedures under the direct and constant supervision of a licensed clinical laboratory scientist that includes following safety guidelines and adhering to approved protocols.
- Conducts laboratory studies using commercial assays performed in the clinical laboratory only affiliated with academic facilities/institutions, and pharmaceutical companies.
- Writes validation plans and summary reports when transferring an assay from the Product Development Department or pharmaceutical assays (clinical trials) into Laboratory Operations.
- Writes and executes validation plans for new laboratory equipment (IQ,OQ,PQ), when necessary.
- Writes standard operating procedures, from operations perspective, of newly transferred/commercial assays from Product Development into the clinical laboratory.
- Participates in the evaluation of new methods and procedures under the direction of the VP of Laboratory Operations or designee.
- Adapts to changes in processes, accepting approved changes and learning new tasks.
- Works cross functionally with other departments (i.e., Quality Systems, Clinical Trials, etc.).
- Participates in continuing education programs, (mandatory and non-mandatory).
- Knowledge of quality systems and quality systems regulations. Knowledge of ISO standards (ISO 9001-2008).
- Follows all MDxHealth Inc.’s health and safety policies and procedures.
Education and Experience
- Must have a minimum of three or more years working in research and development and/or clinical laboratory related experience.
- Master’s degree in chemical, physical or biological science preferred.
- Bachelor’s degree in chemical, physical or Molecular biological science required.