Carly Krystopik Bristol Myers Squibb
Carly is a microbiologist with over ten years of experience, specializing in review of GMP testing and documentation. Ensures current practices are in compliance with industry guidelines and regulatory expectations. Experienced in review of Bacterial Endotoxin (Gel Clot and Kinetic) Routine and Validation, TOC, Conductivity, HPC, Microbial Identification, Bioburden, MLT, Growth Promotion, Antibiotic testing, and AET. Also, skilled in review of autoclave qualifications, Biological Indicator verification and release, and numerous equipment calibrations. Proficient in creation, review and revision of procedures, protocols, reports and forms.
She performs in-process bioburden testing of parenteral products and in-use hold time studies of final products to define commercial labelling requirements.
She performs in-process bioburden testing of parenteral products and in-use hold time studies of final products to define commercial labelling requirements.