Summary
Overview
Work History
Education
Skills
Hobbies
Timeline
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Ayesha Amjad

Chatham,NJ

Summary

Quality Specialist with expertise in managing quality systems compliance, authoring and reviewing SOPs, and driving CAPA and change control processes within the pharmaceutical and biotechnology industries. Proficient in using EDMS including TrackWise for quality management, with a strong focus on regulatory compliance and continuous improvement. Adept at supporting FDA audits and collaborating with cross-functional teams to enhance operational efficiency and product quality.

Overview

3
3
years of professional experience

Work History

QC Investigations Specialist

Legend Biotech
07.2023 - 06.2024
  • Conducted thorough investigations using Trackwise and Comet, ensuring accurate documentation with zero overdue actions and effectiveness check failures.
  • Managed nonconformance and deviation investigations for CAR-T manufacturing, leading to timely and effective CAPA implementation, enhancing product quality and compliance.
  • Collaborated with cross-functional teams to propose and implement process improvements, reducing investigation turnaround times and increasing laboratory efficiency.
  • Played a key role in change management by executing updates and improvements to quality systems, ensuring adherence to FDA and cGMP standards.
  • Provided quality insights and recommendations to management, driving continuous improvement initiatives and maintaining a high level of operational excellence.
  • Regularly monitored and reported on non-conformance and CAPA metrics, contributing to strategic decision-making and ensuring ongoing compliance.

Compliance Associate

Eywa Pharma
08.2022 - 07.2023
  • Spearheaded the management of quality systems compliance for CAR-T manufacturing processes, ensuring alignment with FDA regulations (21 CFR Part 11, 210, 211) and cGMP requirements.
  • Conducted comprehensive investigations of nonconformances and deviations using Trackwise and Comet, driving effective root cause analysis and implementation of CAPAs.
  • Authored and meticulously reviewed SOPs, test methods, and specifications within the electronic document management system (EDMS), ensuring robust documentation and process control.
  • Proactively collaborated with cross-functional stakeholders to implement change controls, optimizing laboratory processes and ensuring regulatory compliance.
  • Diligently reported and monitored Quality Metrics data on non-conformance investigations and CAPAs, contributing significantly to continuous improvement efforts.

Analytical Chemist

Austar Pharma LLC
06.2021 - 08.2022
  • Executed rigorous GMP analytical testing of in-process, final product, and stability samples, ensuring strict compliance with SOPs and regulatory guidelines.
  • Authored and reviewed complex analytical methods, protocols, SOPs, and other GxP documents, contributing to the development of industry-leading documentation practices.
  • Maintained stringent documentation and review processes for GMP testing results, adhering to governing SOPs and regulatory requirements without fail.

Education

Master of Science - Pharmaceutical Engineering

New Jersey Institute of Technology
Newark, NJ
05.2021

Bachelor of Science - Biomedical Sciences (Honors)

University of Manchester
United Kingdom
07.2017

Skills

  • Quality Management Systems (TrackWise, Comet)
  • SOP Authoring & Review
  • CAPA Management
  • Change Control & Regulatory Compliance
  • FDA & cGMP Compliance
  • Audit Support (FDA, Supplier Audits)
  • Quality Metrics Reporting
  • Process Improvement & Root Cause Analysis
  • Project Management & Team Collaboration
  • Problem-Solving Tools (Fishbone Diagram, 5 Whys)
  • Technical Writing
  • Computer & Information Technology Skills (Windows, Word, Excel, Access, PowerPoint, Project, Visio)

Hobbies

Hiking, Dogs, Binging TV Shows, Reading Science Fiction & Fantasy Books

Timeline

QC Investigations Specialist

Legend Biotech
07.2023 - 06.2024

Compliance Associate

Eywa Pharma
08.2022 - 07.2023

Analytical Chemist

Austar Pharma LLC
06.2021 - 08.2022

Master of Science - Pharmaceutical Engineering

New Jersey Institute of Technology

Bachelor of Science - Biomedical Sciences (Honors)

University of Manchester

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Ayesha Amjad