Quality Assurance Teaching Assistant

Dec ****

Ramyashree Doddaballapur

Denton, TX +1-347-***-**** *******************@*******.*** https://www.linkedin.com/in/ramyashreedoddaballapur/ WORK EXPERIENCE

University of North Texas- Graduate Teaching Assistant Aug 2024 – May2025

• Designed and delivered laboratory modules on Python-driven chromatographic data processing (UPLC/LC-MS) and MATLAB-based signal noise optimization to > 40 students, reinforcing method-development fundamentals and Good Documentation Practices (GDP).

• Mentored capstone teams that simulated renal & cardiovascular drug-clearance kinetics, sharpening skills in kinetic modelling and result interpretation for small-molecule studies.

• Instituted an electronic lab-notebook template that cut data-entry errors by 35 %, promoting reproducibility and FDA 21 CFR 11 compliance.

Radiometer Quality Assurance Associate Sept 2022 – Dec 2023

• Ensured compliance with ISO 13485, ISO 14971, and FDA 21 CFR Part 820 for Class II/III diagnostic medical devices, contributing to successful regulatory audits with zero major nonconformities.

• Participated in CAPA investigations and root cause analyses across 15+ quality events, supporting timely implementation of corrective actions and effectiveness checks. Conducted and supported internal quality audits across R&D and manufacturing functions, helping to maintain audit readiness and continuous QMS compliance. Authored and reviewed over 20 technical documents, including SOPs, work instructions, and design history file (DHF) elements, aligning documentation with evolving regulatory requirements.

• Collaborated with cross-functional teams (engineering, RA/QA, and manufacturing) to support risk management activities, including FMEAs and risk control updates.Led initiatives to streamline quality processes, contributing to a 10% reduction in document cycle time within the electronic QMS platform. Centre of Excellence RVCE Research Intern – Computational Genomics Dec 2021 -May 2022

• Processed 2 TB of high-throughput sequencing data; built Python/SQL pipelines that mapped disease-vector ligands and flagged chromatographic outliers (<1 % false positives) for downstream LC-MS confirmation.

• Performed in-silico ligand docking and prioritized lead compounds for chemical synthesis and purification, sharpening structure- activity relationship (SAR) insight critical to small-molecule programs. Pall Corporation Validation Intern Feb 2021 – May 2021

• Conducted bacterial-challenge and filter-retention studies using FDA-compliant protocols; generated chromatograms on Waters™ Alliance HPLC to verify log-reduction targets (>6 log10).

• Wrote validation reports and calibrated spectrophotometers, peristaltic pumps, and pressure-decay testers, ensuring measurement traceability per GMP guidelines.

Apollo Hospitals Histopathology Intern Mar 2020 – May 2020

• Prepared > 500 tissue samples, performing IHC/IF staining and LC-grade solvent handling while maintaining 100 % chain-of-custody accuracy.

• Logged all biospecimen metadata in LIMS, reinforcing data integrity for clinical-phase biomarker studies. PROJECTS

• Designed a BBB-on-a-chip microfluidic system to evaluate drug permeability for CNS-targeted delivery.

• Conducted in silico docking to identify high-affinity natural ligands for ovarian and lung cancer biomarkers.

• Analyzed tumor-specific pathways in lung adenocarcinoma to identify potential drug–target interactions.

• Screened plant-based compounds for vector control through docking and ADMET profiling.

• Developed ML models to classify breast cancer stages using clinical biomarker data and SHAP-based interpretation.

• Performed pan-genome analysis of Aedes aegypti to identify conserved gene clusters for vector control

• Built AI models to predict neurological disorder risk in T2D patients using EHR-derived clinical features. EDUCATION

University of North Texas

Master of Science, Bioengineering and Biomedical Engineering

• Coursework: Bioinformatics and Genomic Data analysis, Computational modeling, Application of machine learning, SKILLS

• Analytical Chemistry & Instrumentation: UPLC, HPLC, LC-MS, SFC (Waters & Agilent), Method Development, Column Selection, Sample Preparation, Instrument Troubleshooting & Calibration

• Molecular & Laboratory Techniques: Yeast/Bacterial Culture, Protein & Small Molecule Purification, PCR, Western Blot, Molecular Docking (AutoDock, PyMOL), Buffer & Media Preparation, Microbiological Testing

• Bioinformatics & Analysis Tools: Biopython, Genome Annotation, PGAP, OmicsBox, Data Visualization (GraphPad Prism, ImageJ, Matplotlib, Seaborn)

• Programming & Workflow Automation: Python, R, SQL, Nextflow, Snakemake, Jupyter Notebooks, Git, Linux/Unix

• Cloud & DevOps Tools: AWS (EC2, S3), GitHub

• Workflow & Automation Tools: Nextflow, Snakemake, Git, Linux/Unix

• Cloud & DevOps: AWS (EC2, S3), Azure, Docker (basic), GitHub

• Compliance Knowledge: GMP, ISO 13485, ISO 14971, FDA 21 CFR 820

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