Description:
The Position: We are seeking a contract position as a Research & Development Technologist/Scientist to work in a team environment working on developing a new assay for our VITROS analyzer systems. You will perform various assignments related to the performance testing of the assay on the VITROS analyzer systems in the laboratory in accordance with cGMP regulations. This position may also include the preparation of complex biological solutions using established protocols, including reconstitution of calibrators and controls. These protocols may include weighing chemicals, volumetric additions of various biological components, pipetting, filtration, ultra-filtration, etc
Responsibilities:
- As part of a technical team operates the VITROS analyzers to complete assay testing experiments aimed for the development of new VITROS in vitro diagnostic products or processes using established protocols and SOP鈥檚.
- Provides technical support by carrying out experimental testing on diagnostic instruments and breadboards.
- Maintains analyzer equipment related to the VITROS testing (daily, weekly, and monthly maintenance) and performs necessary calibration, QC, and documentation according to SOPs.
- Maintains accurate records of work performed in accordance with cGMP and the procedures outlined in the Quality System. This includes Design History files, QC, equipment maintenance, and other associated testing documentation.
- Performs calculations for chemical additions for various fluid formulations, such as interferent testing and sample spiking.
- Maintains a neat, orderly, and safe workplace and cleans work area and analyzer upon testing completion.
- Organizes and tracks reagent, calibrator, and control inventory in refrigerators and freezers.
- Performs training on SOP's, protocols and other laboratory documentations.