Kavya K.
Qc Analyst @Novo Nordisk
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WORK HISTORY
Qc Analyst @Novo Nordisk
West Lebanon, NH, US
Executed high-throughput GMP/QC analytical testing across multiple concurrent projects.> Performed ELISA, UPLC, HPLC, TOC, conductivity, osmolality, pH, and NaCl assays.> Led investigations for OOE/OOS results; drove root-cause analysis and compliant documentation.> Authored and implemented change controls for new QC methods, reagents, and process improvements.> Validated and transferred analytical QC methods to support lifecycle management and continuous improvement.> Managed equipment qualification and asset lifecycle tracking using TIMS.> QC method content owner ensured accuracy, compliance, and periodic document review.> Developed and validated QC workflows in gLIMS Static Building to improve data integrity and efficiency.> Served as SME for QC analytical methods and best-practice implementation.> Established and maintained reagent qualification reports and traceability documentation.> Conducted data review, statistical trending, and performance monitoring to support product quality.> Trained and mentored new analysts in analytical techniques, GMP documentation, and QC procedures.
EDUCATION
Osmania university college of Technology
Master’s of biochemical engineering and biotechnology
University of New Hampshire
Master’s in industrial biotechnology and biomedical science, Biotechnology
Jawaharlal Nehru Technological University
Bachelor’s in Pharmacy
ABOUT KAVYA K.
As a QC Analyst at Novo Nordisk, I focus on executing high-throughput GMP/QC analytical testing and troubleshooting diverse assays such as ELISA and HPLC. My role includes authoring and implementing change controls to enhance quality control methods and processes, validating QC methods, and developing workflows in gLIMS Static Building to improve data integrity. I also lead investigations for OOE/OOS results and manage equipment qualification and asset lifecycle tracking. I bring a strong foundation in quality control and data analysis. My academic background complements my hands-on experience, including my prior contributions at Dyne Therapeutics, where I executed molecular techniques and delivered critical data analysis for drug development. I aim to continue driving compliance, innovation, and efficiency in collaborative laboratory environments.
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