The Scientist I, QC Microbiology role will test and report cGMP test results for the Quality Control Microbiology Laboratory. The hours for this position are 1st shift Sunday through Thursday
• Follows current GMP requirements and complies with company safety and controlled substance handling policies.
• Participates in repair and maintenance of lab equipment and lab housekeeping (disinfection and cleaning).
• Initiates, documents and performs 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 under supervision.
• Performs environmental monitoring, as required; Evaluates and records data.
• Performs quality control testing of media, reagents, and identification materials.
• Maintains adequate inventory of media and materials required for testing.
• Notifies laboratory supervisor when OOS results are obtained; may assist with gathering data and documentation of notifications in TrackWise.
• May assist with special projects as needed.
• Performs data entry for tracking and trending of lab data.
• May assist with revising SOPs, forms and other controlled documents.
• Performs micro identifications using manual testing and automated systems.
• Flexibility in schedule is required.
Bachelor's degree in biology, health science or microbiology.
0-2 years' experience in cGMP micro expertise.