Perform microbiological testing required for water used in the manufacturing process, raw materials, in process samples and final product following specifications. Perform microbiological and chemical testing such as bio burden, endotoxin, TOC, pH and conductivity to water samples used in the product manufacturing process and to the final product. Perform in process product testing such as bio burden, contamination check and endotoxin. Perform all the facilities and utilities environmental monitoring using Clemet, RCS, and surface sampling. Perform gowning sampling as part of routine program and for qualification/routine requirements. Perform other microbiological lab testing such as growth promotion and identification of microorganisms. Provide support in method transfer, equipment/instrument qualification and process validation. Follow Good Manufacturing Practices (cGMP), safety rules and Good Laboratory Practices (GLP).

Responsibilities

• Perform microbiological testing following procedures, methods and specifications within the required time frame.
• Provide support in validations, special sampling, and during planned or unplanned reinstatements.
• Document the test results to all final products, environmental monitoring (EM), water samples following procedures.
• Identify, collect and submit all LIMS required samples.
• Perform identification, growth promotion, and other general microbial testing requirements
• Perform the general cleaning/maintenance of laboratory equipment such as incubators, refrigerators as required per procedures.
• Maintain the materials, reagents, and media inventory required in the MEC laboratory
• Comply with all training certifications as required by position requirements.
• Generates and manages non-hazardous and hazardous waste, according with the internal operating procedures and in compliance with local and federal regulations.