QC Microbiology Analyst

Position Summary:

Responsible for testing bioburden via membrane filtration of facility waters and product

Responsible for testing facility waters and product with Endotoxin KQCL and KTA

Responsible for aseptically sampling water, clean steam, environmental monitoring, and compressed gases per established sampling plans and protocols.

Responsible for performing microbiological testing of water, clean steam, environmental monitoring, and compressed gases per established testing procedures and protocols.

Responsible for performing Gram staining and microbiological identification of environmental monitoring samples

Documentation of testing activities per cGMP requirements.

Responsible for the review of laboratory data

Authors Invalid and Out Of Specification (OOS) laboratory investigations

Requirements:

Bachelor's degree in Scientific Discipline.

One year experience preferred in:

o GMP laboratory experience and aseptic techniques for pharmaceuticals

o Performing bioburden, Gram staining, microbial identification, and endotoxin testing for facility water or product as required

o Proficient in the use of Microsoft Word, Excel, and Laboratory information management systems preferred.