Microbiologist I in Rancho Cordova, California at AMPAC Fine Chemicals

The main responsibilities include sampling and testing purified and potable water systems, performing environmental monitoring in cGMP manufacturing facilities, and testing drug substances per USP guidelines.

Water testing methods include Total Organic Carbon, Conductivity, Total Plate Count by Pour Plate and
Membrane filtration, Coliforms, and Endotoxin.

Environmental monitoring methods include non-viable particulates, viable air, and surface sampling in the cGMP manufacturing areas.

Drug substance testing includes development of counting methods in the presence of product and subsequent testing of the drug substances per the developed methods. Testing methods are based on the guidelines
outlined in USP

The candidate must be able to apply knowledge of cGMP and GLP on a daily basis. Perform data entry into electronic and paper files. Track inventory and order laboratory consumables for routine testing.

This is a unique opportunity to join a growing microbiology lab in a cGMP environment.

B.S. degree in Microbiology or in Biological Sciences which includes coursework in Microbiology. Minimum 2-5 years of microbiology laboratory work experience in a medical devices/pharmaceutical/GMP environment.

Skills: Knows and appropriately applies aseptic technique during sampling and testing. Performs subculture and gram staining of microorganisms. Thorough understanding of environmental monitoring and clean room operations. Good verbal and written communication skills. Must have a commitment to task, take responsibility for actions and outcomes. Demonstrated attention to detail by following procedures and ensuring accuracy in
documentation and data. Able to prepare for testing and plan for multiple activities. Applies appropriate sense of urgency when organizing, prioritizing and scheduling tasks. Follows standard procedures. Maintain high standards for quality; reinforce excellence as a fundamental priority. Solid computer skills using MS Excel and MS Word.