QC Microbiology II

职位描述

Knowledge:
Basic Knowledge of current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.
Basic Knowledge of general Microbiology techniques such as gram staining, aseptic technique, and plate streaking technique.
Knowledge of USP and other regulatory requirements.
Knowledge of HPLC and UPLC systems.
Proficiency in Microsoft Office applications.
Ability to work effectively in a team environment.
Strong verbal, written, and interpersonal communication skills are required.
Specific Education & Experience Requirements:
0 years of relevant experience and a BS degree in relevant fields.
Prior lab experience preferred.
Specific Job Responsibilities:
Conducts procedure updates in QC lab and GMP reviews of logbooks
Coordinates waste management, LEAN and 5S efforts as required.
Responsible for performing microbiological testing of raw material, in process, final product, validation-related, and critical utility samples.
Prepares growth promotion and other applicable nutrient substrate media qualification. Performs bioburden testing of water and product.
Performs environmental monitoring including surface viable air, non-viable air and personnel monitoring.
Performs endotoxin testing using kinetic chromogenic methodology. Performs environmental and/or critical utility monitoring as required.