The Quality Anaylst I, Microbiology is responsible for performing daily lab operations with the assigned functional area related to the release of product, and/or monitoring of the IMF environment, as well as complete other assigned duties.
Performs routine environmental monitoring, including air viable, particulate, viable surface sampling, and purified water system sampling/testing.
Performs assays for qualifying raw materials and for release or stability testing of in-process and finished products. These test methods may include flow cytometry, ELISA, endotoxin, complete blood count, viability, gram stain, growth promotion, and sterility.
Receives and maintains traceability and integrity of test samples, reagents and materials used in the laboratory per approved procedures.
Initiates and takes ownership as needed of laboratory investigations and exception reports for out-of-limit samples, and of other projects and related assignments.