Summary
Overview
Work History
Education
Skills
Timeline
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Swathi Yaramala

Folsom,CA

Summary

Determined Quality Assurance Specialist with dedication to quality and accuracy. Familiar with handling multiple projects in highly competitive environments. Solid interpersonal and collaboration skills.

Overview

11
11
years of professional experience

Work History

QA Specialist

Edmonton Radiopharmaceutical Center
01.2022 - 07.2023
  • Reviews documentation such as batch logs and shipments for accuracy, completeness, and adherence of cGMPs.
  • Assists in gathering data for GMP and customer audits.
  • Review and updates Sop’s as needed.
  • Updated inspection journals and daily summary logs with quality-related data.
  • Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
  • Monitored product standards and quality-control programs.
  • Addressed non-conformance issues, pausing production to correct errors.
  • Implemented process improvements to increase productivity in quality assurance operations.
  • Reported problems and concerns to management.
  • Developed and implemented procedures to meet product quality standards.
  • Assessed products or services to evaluate conformance with quality standards.
  • Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
  • Reviewed production processes and identified potential quality issues.
  • Conducted investigations into questionable test results.
  • Interpreted test results by comparing to established specifications and control limits, making recommendations on appropriateness of data for release.

Voluntary Worker

Edmonton Radio-pharmaceutical Center
08.2021 - 12.2021

Community Support Worker

Pacific Coast Community Resources
05.2019 - 03.2021

Teaching Assistant

Seoul National University
02.2012 - 02.2013

Education

Regulatory Affairs Essential Program - Regulatory Affairs

University of California - San Diego
La Jolla, CA
09.2023

Master of Science - Nursing

Seoul National University
Seoul, South Korea
02.2015

Bachelor of Science - Nursing

Dr NTR University of Health Sciences
Andhra Pradesh, India
01.2012

Skills

  • Strong background in FDA drug safety guidelines
  • Attention to detail
  • Excellent research skills
  • Microsoft Office, Excell, PowerPoint Proficiency
  • Problem solving skills
  • Team player
  • Possesses proficiency in reviewing and approving deviations, change controls, work orders, protocols, reports, batch records, and other GMP documents
  • Performs other tasks as assigned
  • Stay up to date with all training materials/activities
  • Helps ensure QA group is consistent in making decisions by fostering constant team communication
  • Maintains efficient and effective QA procedures

Timeline

QA Specialist

Edmonton Radiopharmaceutical Center
01.2022 - 07.2023

Voluntary Worker

Edmonton Radio-pharmaceutical Center
08.2021 - 12.2021

Community Support Worker

Pacific Coast Community Resources
05.2019 - 03.2021

Teaching Assistant

Seoul National University
02.2012 - 02.2013

Regulatory Affairs Essential Program - Regulatory Affairs

University of California - San Diego

Master of Science - Nursing

Seoul National University

Bachelor of Science - Nursing

Dr NTR University of Health Sciences

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Swathi Yaramala