Perform daily environmental monitoring and assist in collection and transfer of samples for laboratory analysis.
Perform microbiological in-process and release testing in support of GMP manufacturing. Tests include, but are not limited to: bioburden, microbial purity and endotoxin.
Execute environmental monitoring (EM) within all classified manufacturing areas according to approved SOP’s and cGMP’s.
Provide EM support for manufacturing during specified dynamic conditions.
Execute water and steam sampling throughout the facility.
Perform limited clerical duties, such as data entry and report preparation.
Additional duties for Senior Associate:
Review EM data for completeness and accuracy and assist with data trending.
Initiate and author laboratory and deviation investigations.
BS in scientific discipline with 0+ (Associate), 2+ (Senior Associate) years’ experience performing microbiological, biochemical and/or analytical methods in a GMP environment. Senior Associate is expected to execute tasks with minimal supervision.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or Vietnam veteran status, are strongly encouraged to apply.