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Senior Quality Control Microbiology Technician
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- Perform assigned quality control activities within the Microbiology Department to comply with applicable SOP's and cGMPs∯*∯ Work under limited supervision with considerable latitude for the use of initiative and independent judgment.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc
- Employ aseptic techniques while performing Sterility, Endotoxin, Particulates and Bioburden testing of drug products, intermediates and raw materials per USP and Company's Standard Operating Procedures (SOP)
- Perform in vivo biological performance testing of final product in support of product efficacy and quality per USP and Company's Standard Test Methods
- Data entry and review in Laboratory Management Systems (LIMS).
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