This position is responsible for performing microbiological tests that support the release of intermediates and finished products. These include routine and non-routine microbiological tests on in-process and final container products, as well as environmental monitoring samples.
Responsibilities
- Perform testing of microbiological samples including bioburden and sterility testing.
- Perform environmental monitoring.
- Collect water samples and perform associated testing.
- Monitor cultures for the presence of microbial growth per FDA, GMP and in-house company standard operating procedures.
- Perform and report bacterial identifications for environmental isolates.
- Perform housekeeping duties in the clean-rooms and laboratory, including assigned monthly cleaning.
Qualifications
- Bachelor’s degree in Microbiology or a related scientific field.
- ??????Pharmaceutical & FDA/GLP industry experience is preferred over academic laboratory experience.Microbiology laboratory skills and knowledge, such as aseptic techniques, is required.
- Demonstrated understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Must be legally authorized to work in the United States and willing to submit to a pre-employment background check and drug screen
