Sherry Bogle
Microbiologist Ii Lead @Rising Pharmaceuticals
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WORK HISTORY
Microbiologist Ii Lead @Rising Pharmaceuticals
Decatur, IL, US
Author and track quality events for the department including deviations, CAPAs, change controls, and effectiveness checks. Author and review SOPs and protocols in trackwise• Prepare work schedules for Microbiologists, provide training for new employees, and maintain media and microbial culture inventory• Cultivate and calibrate microbial cultures for various test applications• Perform method suitability and quality control testing of water samples, API, and drug product for BET, sterility, and bioburden. Perform QC testing of incoming media, reagents, biological indicators, and microbial organisms for release• Collaborate cross-functionally with other departments to close quality events, obtain input for new and ongoing projects, and receive necessary materials
EDUCATION
University of Illinois Springfield
Bachelor of Science (B.S.), Clinical Laboratory Science, Minor in Chemistry, Clinical Laboratory Science/Medical Technology/Technologist
ABOUT SHERRY BOGLE
Senior Microbiologist with over 28 years of laboratory experience and over 22 years of experience in the pharmaceutical industry in quality testing and drug development. I am detail oriented, efficient, self-motivated, and work independently, with a proven track record for meeting assigned project timelines. I have extensive experience in authoring and reviewing CMC regulatory submission documents for over 60 ANDA and ANADA product submissions to the FDA for human and animal health sterile injectables, sterile ophthalmics, and oral dosage forms. I have extensive experience collaborating with colleagues and CMO clients on cross functional teams, both international and domestic at all levels within the organizations. I served as the Microbiology Subject Matter Expert, for Microbiology related issues for products under development as well as commercial products at CMOs. I am eager to further my personal and professional development in research, regulatory, technical writing, or positions in procurement.
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