Quality Control Regulatory Compliance

Shreeya More

240-***-**** ***************@*****.*** LinkedIn

Detail-oriented Pharmaceutical Sciences graduate with 2+ years of experience in quality control, research, and pharmaceutical operations. Proficient in analytical techniques such as qPCR and HPLC, with a strong focus on generating and interpreting precise data. Experienced in maintaining strict adherence to SOPs, GMP standards, and regulatory compliance. Skilled in documentation, data review, and operating advanced laboratory instruments to ensure product quality and consistency.

TECHNICAL SKILLS

Tools: MS Office (Excel, PowerPoint, Visio, SharePoint), Electronic laboratory notebook (ELN) Software: Rinmr, Winfit, Origin, PyMOL, UniProt, BLAST, Snapgene, EMPOWER Equipment: High field NMR, Beckman Coulter ViCell, Dynamic light scattering spectrometer, UV – Spectrophotometer, Autoclave, Incubator, Centrifuge, Vortex, and Minispec Bruker NMR Core competencies: Good laboratory practice (GLP), Handling mammalian cell cultures, Serial dilutions, Aseptic Technique, analytical techniques, micro pipetting, aliquot, perform calculations, write lab reports, mass spectrometry, tandem mass spectrometry, upkeep lab notebook, cell culture, create stock solutions, devise experiments, SDS-Page and perform site mutagenesis, proficient in HPLC, Western Blotting and PCR. Professional affiliation: Registered pharmacist – Maharashtra state pharmacy council EDUCATION

Master of Science, Pharmaceutical Sciences Dec. 2024 University of Maryland School of Pharmacy Baltimore, MD Bachelor Pharmacy July 2023

Savitribai Phule Pune University Nashik, India

EXPERIENCE

Research Intern Jun. 2024 – Current

Institute for Bioscience and Biotechnology Research Rockville, MD

• Investigating the impact of varying sucrose concentrations on the movement of Fab monoclonal antibodies (mAbs) by analyzing and processing experimental data across multiple formulations.

• Performed CHO cell culture analysis using water proton NMR, correlating cell viability and count with relaxation data to enhance understanding of cellular responses under varying conditions.

• Utilized ViCell automated cell counter for accurate and reproducible quantification of CHO cells, supporting reliable integration with NMR data for robust analysis.

• Conducted correlation studies using NMR and cell count data with statistical tools; presented findings in a poster at the University of Maryland School of Pharmacy. Data Analyst May 2023 – Aug. 2023

Objectways India

• Processed and cleaned raw data sets to ensure high-quality and consistent input for annotation tasks, improving data integrity for subsequent analysis.

• Utilized advanced annotation tools and platforms to efficiently label large volumes of data, contributing to faster project turnaround and enhanced data usability.

• Collaborated on multiple annotation projects by adhering to precise standards, ensuring 100% compliance with project requirements, leading to consistent and reliable outputs. ACADEMIC RESEARCH

Formulation and Evaluation of Herbal Liquids for Treatment of Migraine Dec. 2022 - Jun. 2023

• Conducted a comprehensive literature review on herbal formulations for migraine treatment, analyzing over 50 peer-reviewed articles and identifying key active ingredients and their efficacy rates.

• Developed a systematic evaluation framework for herbal liquid formulations, incorporating factors such as bioavailability, stability, and patient compliance, resulting in a 30% improvement in assessment accuracy. HPLC Analysis Experience

• During my undergraduate studies in Pharmaceutical Sciences, I gained hands-on experience with High- Performance Liquid Chromatography HPLC analysis for capsule and tablet analysis.

• Capsule and Tablet Analysis: Method Development: Developed and optimized an HPLC method for the analysis of specific compounds in capsule and tablet formulations. Performed HPLC analysis using a HPLC model.

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