Manage the stability samples following established specifications and performs physical and chemical analysis to stability products. Perform general task assigned by the Lab ManageResponsibilitiesHandles, labels, stores, and pulls stability samples for testing. Performs physical and chemical analyses: viscosity, pH, assay, identity, specific gravity, and others. Monitors temperature and humidity of stability chambers/ovens. Prepares and ships samples for external testing and HUT. Maintains inventory of stability samples. Performs basic calibration of laboratory equipment. Prepares test and volumetric solutions for laboratory analysis. Ensures compliance with cGMP, SOPs, and written procedures. Accurately records analytical results in lab notebooks and reports.
Manages and coordinates the disposal of hazardous waste. Reports out-of-specification results, errors, or inconsistencies to Lab Manager. Keeps supervisor informed on testing progress and findings. Supports other stability-related tasks as assigned. Qualifications: Bachelor’s Degree in Science and at least two (2) years of experience in an analytical laboratory or equivalent combination of education and experienceOthers Skills: Solid understanding of industry standards and regulations, including GMP, GLP, USP, EP, FCC, OSHA, and ISO-13485. Proficient in Microsoft Office tools (Excel, Word, etc. ). Fully bilingual – fluent in English and Spanish (spoken and written).
Strong ability to work under pressure, meet deadlines, and manage multiple tasks efficiently. Successfully passes color vision (color blindness) test.
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