Perform daily environmental monitoring and assist in collection and transfer of samples for laboratory analysis and reporting of results.
- Performs microbiological in-process and release testing in support of GMP and non-GMP manufacturing. Tests include, but are not limited to, bioburden, mycoplasma and endotoxin.
- Execute environmental monitoring within all classified manufacturing areas according to approved SOP’s and cGMP’s.
- Review EM data for completeness and accurate, and assist with data trending.
- Provide EM support for manufacturing during specified static and dynamic conditions.
- Perform limited clerical duties, such as data entry and report preparation.
- Bachelor's degree in scientific discipline with at least 1 year of experience with performing microbiological methods including bioburden, mycoplasma and endotoxin. Alternatively, an Associate's degree and at least 3 years of experience is acceptable. Experience with environmental monitoring collection and reporting is highly desirable.