Laboratory Technician I-Department of Neurosurgery-GMP
About The Position
The primary responsibilities of this position are conducting procedures for Environmental Monitoring of the GMP facility of the HAL and the Cancer and Genetics Facility during the course of a clinical manufacturing. Maintaining the laboratory in working conditions in compliance with GMP standards, that include inventory tracking and ordering, maintaining proper inventory in compliance with GMP and in compliance with EH&S and Radiation Safety, maintaining laboratory and laboratory equipment in clean and working conditions at all times, logging in samples and reagents/materials, responsible for monitoring lab, including overseeing hazardous waste disposal, radioactive waste disposal and keeping protocols and chemicals and radioactive material inventory up-to-date. Maintaining an up-to-date training on standard operating procedure (SOPs) as overviewed by the QA unit, as well as on safety protocols in compliance with EH&S, Radiation Control safety. Review and revision of GMP SOPs. Testing of clinical-grade preparations in compliance with cGMP for the qualitative and quantitative assessment of New Investigational Drugs (INDs) to be used in clinical trials at UF or elsewhere. These activities require strict adherence to written protocols, proper reporting and data entry. The release of clinical drugs will depend on the result from these activities, upon review by the PI (principle investigator) and the independent Quality Assurance unit. During the course of these assays, the candidate will perform standard laboratory techniques that include, but are not limited to, cell culture, molecular biology (PCR, western blot, dot blot, hybridization, protein and nucleic acid electrophoresis), microscopy, pH, and conductivity. These activities included reagent preparations, storage and tracking of expiration date in compliance with GMP. [10%] - Clinical assay, clinical sample receiving, logging in, tracking, and sample processing for testing, storing, shipping. Assistance with facility and equipment cleaning and maintenance will also be required.
Requirements
- Associate's degree in an appropriate area; or a high school diploma or equivalent, and two years of related experience.
- Appropriate college coursework or vocational/technical training may substitute at an equivalent rate for the required experience.
Nice To Haves
- Experience with clean room work and GLP/GMP regulations, as well as mammalian cell culture andvirology.
- Bachelor’s degree in biology, microbiology, biochemistry or animal sciences.
Responsibilities
- Conducting procedures for Environmental Monitoring of the GMP facility
- Maintaining the laboratory in working conditions in compliance with GMP standards
- Inventory tracking and ordering
- Maintaining proper inventory in compliance with GMP and in compliance with EH&S and Radiation Safety
- Maintaining laboratory and laboratory equipment in clean and working conditions at all times
- Logging in samples and reagents/materials
- Responsible for monitoring lab, including overseeing hazardous waste disposal, radioactive waste disposal and keeping protocols and chemicals and radioactive material inventory up-to-date
- Maintaining an up-to-date training on standard operating procedure (SOPs) as overviewed by the QA unit, as well as on safety protocols in compliance with EH&S, Radiation Control safety
- Review and revision of GMP SOPs
- Testing of clinical-grade preparations in compliance with cGMP for the qualitative and quantitative assessment of New Investigational Drugs (INDs) to be used in clinical trials at UF or elsewhere
- Clinical assay, clinical sample receiving, logging in, tracking, and sample processing for testing, storing, shipping
- Assistance with facility and equipment cleaning and maintenance
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
