Performs various types of microbiological testing under minimal or no supervision. Evaluates and records data. Provides training and support for less experienced members of the lab. Assists Lab management in trending and reporting data, and in investigations.
• Reviews documentation for compliance to GMP and test methods.
• Follows current GMP requirements and complies with company safety policies. Participates in repair and maintenance of lab equipment and laboratory housekeeping (disinfection and cleaning).
• Initiate, document, and perform microbiological analysis on received test samples (including raw materials, bulk, final product, stability, water) as per USP, in-house, or customer methods. Evaluates and records data.
• Complies with controlled substance handling.
• Performs bioburden testing on pre-sterilized bulk product and/or components. Evaluates and records data.
• Performs environmental sampling. Evaluates and records data.
• Performs quality control testing of media, reagents, and identification materials.
• Performs microbial identifications using manual testing and automated systems.
• Maintains lab stock cultures for evaluative testing and make dilutions of stock cultures as required by procedure, protocol, or USP requirements.
• Maintains adequate inventory of media and materials required for testing.
• Notifies laboratory supervisor, or designee, when out-of-specification results are obtained, writes deviation reports, and completes appropriate documentation and assists in the investigation.
• Assists in special projects as assigned.
• Performs data entry for tracking and trending of lab data.
• Writes and revises SOPs, forms, protocols, and other controlled documents.
• Maintains intra and interdepartmental communication to support company goals.
• Provide schedule flexibility when directed.