The Microbiologist II will be responsible for performing microbiological testing of cGMP controlled areas, pharmaceutical grade water, and in-process materials in compliance with cGMP guidelines and SOPs.
• Environmental monitoring of cGMP controlled areas.
• Total particulate count monitoring of controlled areas.
• Sampling and testing of pharmaceutical grade water.
• Microbial identifications.
• Growth promotion.
• Bioburden, Endotoxin, Biological Indicator, and Sterility testing.
• Gown qualification.
• Accurate and thorough documentation.
• Proficiently perform all qualified testing methods used by the Microbiology department.
It is each employee’s responsibility to perform their work properly and ensure a product or service meets the current Good Manufacturing Practice (cGMP) requirements for Safety, Identity, Strength, Purity, and Quality. It is each employee’s responsibility to immediately report observations regarding anything that deviates from established standards to their supervisor and to the Quality function.