Descripción del Empleo:
• Performs laboratory analysis or tasks following established procedures & in full compliance with current governmental regulations, official compendia & any other policy/regulation to generate reliable & timely results, to comply with releases due date, reducing cycle time, & providing internal/external customer satisfaction.
• Bacterial endotoxin, sterility test, bioburden/microbial limit, growth promotion, particulate matter to parenteral products, microbial identification, pH test, osmolality, density, protein concentration & other analysis related to the release of the products being manufactured.
• Do microbial analyses of: manufacturing utilities
• Preparation & sterilization of materials needed for the analysis such as culture media & the depyrogenation/sterilization of glassware.
• Environmental surveillance of aseptic & oral dosage, viable/non-viable monitoring.
Bachelor Degree in Biology, Biotechnology, Medical Technology, Microbiology or Industrial Microbiology.
• One (1) year of working experience in a Microbiology Laboratory of a Pharmaceutical Industry.
• Knowledge in laboratory aseptic procedures in a pharmaceutical industry.
• Knowledge of compliance requirements, cGMP, GLP & FDA regulations & the ability to interpret and apply them.
• Technical Skills: Knowledge in general laboratory instrumentations such as incubators, sterilizers, oven, scales, pH meters, air samplers, microscopes, Biohazards, UV, densitometer, conduct meter & Laminar Flow Hoods
• Accurate visual inspection is necessary for the recognition of positive microorganism growth
• 20/20 visual eye accuracy with or without correction & good perception of yellow color