Microbiologist

Responsible for managing and setting the direction of the QC Laboratory operations (Microbiology) in a Sterile cGMP environment. Main responsibility is to assure the reliability of all data generated by the Quality Control Laboratory, and provide support for the Sites environmental monitoring program.

Major Responsibilities:
Supervision, training and development of reporting QC Microbiology staff, and provide guidance on best aseptic practices for all aseptic (Sterile) area personnel.Management of the Environmental Program, as backup to the Site Microbiologist.Trend analysis and evaluation of critical system data; this may include environmental monitoring reports.Management adherence to the budget for the Microbiology Laboratory.Responsible for Environmental, Health, and Safety complianceCommunication with manufacturing, aseptic facilities, and external department staff on microbiological and environmental operational issuesProvide support for all environmental excursions at the Site, with identification of root cause and effective CAPA. This also includes media fill and sterility failure investigations.Serve as reviewer of facility, equipment and product test data and reportsRepresent QC laboratory in a technical expert capacity on microbiological method qualifications, special studies and validations when required.Manage and coordinate new product bioburden, sterility, endotoxin and sub-visible particulate method qualifications for new CDMO clients.Performs special projects and other duties as assigned.