QC Microbiologist II

The QC Microbiologist II will have several responsibilities in the QC group. The analyst will perform environmental monitoring (EM) for particulates and viables in support of cGMP manufacturing which includes several production suites of ISO class 5 7 and 8 as well as EU Grade A to D in a GMP facility that produces biopharmaceuticals (vaccines biologics viral vaccines monoclonal antibodies etc.). In addition monitoring of purified water and compressed gases systems is required. Additional responsibilities may include EM data review and compilation of data report writing and trending of data; investigations gowning training and annual gowning qualification.

• Perform environmental monitoring for HVAC (viable air viable surface total particulates) personnel monitoring purified water (conductivity TOC bioburden).
• Perform entry of data as needed into EM database. Assist in generation of quarterly and annual trend reports.
• Participate in visual inspection program of final products as part of fill-finish activities.
• Perform sample log-in assignment of accession numbers and coordinate shipment of samples to outside test labs.
• Perform microbiological testing such as conductivity TOC bioburden endotoxin growth promotion etc.
• Perform QC Laboratory testing accurately and to schedule as per written procedures. Record all data observations and QC results accurately with attention to detail.
• Order and maintain laboratory reagents and supplies.