Summary
Overview
Work History
Education
Skills
Certification
Projects
Research
Technical Skills
Timeline
Generic

Nikitha M

Charlotte,NC

Summary

Analytical chemist with two years of experience in quality control, validation, and method development. competent in GC, MS, and HPLC with a track record of increasing lab productivity and adherence to regulatory and GMP requirements. competent in managing cross-functional cooperation between R&D, QC, and regulatory teams, streamlining analytical workflows, and spearheading continuous improvement initiatives. knowledgeable about transferring technology, putting quality processes into place, and making sure that all documentation is correct and compliant to support both product quality and regulatory compliance.
shown ability to raise pharmaceutical and healthcare standards by careful work at Karthikeya Drugs & Pharmaceuticals Pvt. Ltd. and UChicago Medicine. As a cross-functional team member and HPLC expert, I have made a substantial contribution to regulatory compliance and quality control by carefully protecting data privacy and optimizing analytical techniques.

Overview

7
7
years of professional experience
1
1
Certification

Work History

UChicago Medicine
Chicago, IL
05.2024 - 08.2024
  • Worked with the Record Viewer activity in Epic to identify master files and related records, using search capabilities to locate networked records, and understand their connections within the Epic build.
  • I shadowed an analyst while fixing the links in the tools menu that point to SharePoint sites and external URLs.
  • Participated in the Epic May 2024 Upgrade meetings while the team is reviewing the Epic Nova notes (upgrade release notes detailing new functionality and configuration steps) and team discussions, along with project timelines.
  • Reviewed the provider teams' build manual to configure the provider teams for the PICU unit pilot. This will include merging existing patient lists to optimize provider assignment.
  • Attended weekly team meetings to review open Sherlock tickets opened by analysts, and identify steps to mitigate issues or to seek assistance with the build.
  • Analyzed business goals, objectives, and needs within the organization.
  • Participated in networking events with leaders and other interns.
  • Participated in department meetings and events (i.e., monthly Diversity and Inclusion events, department-wide team building events, weekly meetings to ensure team alignment, etc.).
  • Evaluated the medical necessity of some procedures and benefit determinations on a timely basis.
  • Analyzed procedure codes to align processes and medical policies.
  • Managed confidential health information in adherence to HIPAA regulations, ensuring data privacy and security.

Junior Research Assistant

Karthikeya Drugs & Pharmaceuticals Pvt.Ltd
07.2017 - 01.2019
  • Managed QC testing, including analytical chemistry, stability studies, and wet chemistry methods, including chromatography, pH meters, spectroscopy, filtrations, and sample preparation.
  • Overseen the operations of the Quality Control Laboratory, and led research scientists and analytical chemists.
  • Conducted QC testing, made considerable use of HPLC, and used fundamental GC and MS skills to assist in the analysis; kept meticulous records using Microsoft Office, lab notebooks, and LIMS software.
  • Created and executed quality systems that managed QC operations, optimized processes, and adhered to GMP standards for product quality and consistency, all in line with worldwide regulatory norms.
  • Established and put into effect standard operating procedures (SOPs) that preserved precision and uniformity in laboratory operations, therefore guaranteeing regulatory compliance.

Education

Master of Science - Masters in Health Informatics

Governors State University
Park Forest, IL
08-2024

Master of Science - Master of Public Health

Central Queensland of University
Melbourne, Australia
11-2020

Bachelor of Science - Bachelor Of Pharmacy

Geethanjali College of Pharmacy
India
06-2017

Skills

  • Analytical Techniques:High-performance liquid Chromatography (HPLC) Gas Chromatography (GC) Quantification of Active Pharmaceutical Ingredients (APIs) Wet chemistry techniques UV-VIS spectrophotometer Chromatography
  • Method Development and Optimization: Analytical Method Development Method Validation Protocols Optimization of Analytical Methods
  • Laboratory Management: Quality Control (QC) Laboratory Operations Regulatory Compliance (GMP, SOP development) Comprehensive QC Testing Stability Testing Instrument Calibration and Maintenance
  • Quality Systems and Compliance: Development and Implementation of Quality Systems Adherence to International Regulatory Standards Efficiency Program Implementation
  • Cross-functional Collaboration: Collaboration with R&D, Quality Control, and Regulatory Affairs Cross-Functional Team Coordination

Certification

Certificate III in Community Pharmacy| Melbourne, Australia|
Support the Supply of Pharmacy Medicines & Pharmacist Only Medicines|October 2021

Certifying my achievement as the recipient of the Participation in the Comprehensive Skill Competition. This recognition underscores my commitment to excellence and proficiency in diverse skills within the academic setting.

• Licensed in Pharmacy |India|

Projects

Big Data Analytics:

  • Delivered impactful presentations showcasing expertise in deriving actionable insights from complex datasets.
  • Explored practical applications of Big Data tools, demonstrating proficiency in harnessing data-driven insights.

Seamless Data Management with Apache Hadoop:

  • Presented impactful sessions highlighting proficiency in extracting actionable insights from intricate datasets.
  • Explored real-world applications of Big Data tools, showcasing expertise in utilizing data-driven insights effectively.

Enhancing LinkedIn User Experience via Apache Pig:

· Revealed the potential of Apache Pig's robust capabilities in elevating the user experience on LinkedIn.

· Utilized data insights to optimize service offerings and enhance user engagement, fostering more personalized interactions.

Research

Epidemiology of Tuberculosis

  • Conducted a research project during the master's program, focusing on the epidemiology of Tuberculosis in the United States.
  • Analyzed epidemiological data to identify trends and patterns related to the transmission and spread of Tuberculosis.
  • Presented findings to faculty members and engaged in discussions on preventive measures and control strategies.

Healthcare Security in Healthcare Law:

  • Researched a significant security breach within the Healthcare Law course.
  • Analyzed the legal and ethical ramifications of the breach, specifically its impact on patient confidentiality and regulatory compliance.

Formulated proactive strategies to enhance healthcare data security, aligning legal and ethical dimensions for robust patient information protection.

Technical Skills

Programming   Languages

Python (beginner), SQL   (beginner), SAS programming

Computer   Skills

MS Word, MS PowerPoint,   MS Excel

Web   Development

ASP.Net Core (beginner)

Electronic   Health Record (EHR)

Practice fusion

Languages

Fluent: English, Telugu,   Hindi

Timeline

UChicago Medicine
05.2024 - 08.2024

Junior Research Assistant

Karthikeya Drugs & Pharmaceuticals Pvt.Ltd
07.2017 - 01.2019

Master of Science - Masters in Health Informatics

Governors State University

Master of Science - Master of Public Health

Central Queensland of University

Bachelor of Science - Bachelor Of Pharmacy

Geethanjali College of Pharmacy
Nikitha M