All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.Overview
The purpose of this role is to test and report cGMP test results for the Quality Control Microbiology Laboratory. Responsibilities
· 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.Qualifications
- Bachelor's degree in biology, health science or microbiology.
0-2 years' experience in cGMP micro expertise.