Microbiologist - Full-time / Part-time

 Performs laboratory analysis or tasks following established procedures.The analysis are: bacterial endotoxin, sterility test, bioburden / microbial limit, growth promotion, particulate matter to parenteral products, microbial identification, pH test , ,osmolality, ,density, protein concentration and other analysis related to the release of the products being manufactured.
In addition do microbial analyses of: manufacturing utilities (i.e. water, clean condensate, compress air, nitrogen, etc.),. The tasks are: preparation and sterilization of materials needed for the analysis such as culture media and the depyrogenation / sterilization of glassware. Environmental surveillance of aseptic and oral dosage form manufacturing and packaging facilities which includes viable (air, surface personnel) and non-viable monitoring. Generates environmental trends and graphs of the controlled environments, post then in the manufacturing areas and discuss them with manufacturing personnel. Audit of aseptic techniques and adequate behavior within the controlled manufacturing environment. Documents if necessary inadequate behavior and generates audit corrective actions if required.
Trains the manufacturing personnel in environmental monitoring sampling and other aseptic processing techniques.
Generates Microbiology /Chemistry Laboratory Investigations Reports (MLIR) and assist in the investigation of out of levels, out of limits and out of trends.
Operates laboratory equipment (such as air viable monitoring instruments ; non-viable monitoring devices for particulate matter analysis, Vitek, Micro-seq or other similar equipment use for microbial identification; microscopes; Laminar Flow Hoods and Biosafety Cabinets for the handling of biohazardous material; autoclaves; glassware washer; ovens; incubators, refrigerators; freezers; microplate readers; chart recorders, balances and pH meters, UV, density meter ,conduct meter and other microbiology laboratory equipment.
Executes test method, process validation and equipment validation test as per corresponding protocols.
 

Requirements:
• 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 and FDA regulations and 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 and Laminar Flow Hoods
• Accurate visual inspection is necessary for the recognition of positive microorganism growth
• 20/20 visual eye accuracy with or without correction and good perception of yellow color
• Approve with pass the sight screening test established within the Microbiology Standard Operating Procedure (SOP)

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