Harshitha K.
Qc Analyst Microbiologist at Agenus
Based in United States
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Seniority
Staff
Department
Science
Location
United States
Industry
Biotechnology Research
Company size
214
Contact information
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Background
About Harshitha K.
Experienced Quality Control Analyst with over 6 years in the pharmaceutical and biotech industries, specializing in analytical testing, microbiology. Proficient in operating and troubleshooting instruments such as HPLC, FTIR, UV/Vis, and particle size analyzers, with expertise in testing raw materials, finished products, stability samples, and water systems under cGMP, GLP, and FDA 21 CFR Part 11 guidelines. Skilled in cleanroom environmental monitoring (Grade A/B/C/D), bioburden testing, method validation, LIMS data review, and managing OOS/OOT investigations. Dedicated to ensuring data integrity, regulatory compliance, and continuous quality improvement in pharmaceutical manufacturing.
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