Summary
Overview
Work History
Education
Skills
Systems
Testing Equipment
References
Timeline
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Aoife McCormack

Kingsford,NSW

Summary

Most recently employed as a QC Technical Lead within the Raw Materials department in Bristol-Myers Squibb with over 5 years' experience in the pharmaceutical industry. Recently completed a level 9 master's degree in Validation Technology and seeking to progress my career with a new role within the scientific industry in Sydney.

Overview

6
6
years of professional experience

Work History

QC Raw Materials Technical Lead

Bristol-Myers Squibb
04.2023 - 03.2024
  • Experience with working with cross functional teams across BMS
  • Involvement in qualification of new equipment (approver of URS, DQ, IOQ and PQ documentation)
  • Conducting audit walk downs to ensure GMP / GDP / GLP
  • Involved in the introduction of new Raw Materials for use in the manufacturing process
  • Experience with method validation including authoring validation protocols, managing protocol executions and report writing
  • Authoring, review, and approval of quality investigations / deviations
  • Management of Technical transfers, Verifications and Validations for Raw Materials in the QC laboratory and Contract test laboratories
  • A representative for QC Raw Materials during audits including conducting lab tours for auditors and addressing all queries relating to the QC Raw Materials department
  • Experience with change controls as a change owner, completing impact assessments and change actions
  • Providing technical expertise for methods and equipment
  • Determining the weekly testing schedule for the QC Raw Materials laboratory
  • People manager for the QC Raw Materials Intern
  • Involvement in the hiring process including CV selection and interviewing.

QC Senior Specialist Raw Materials

Bristol-Myers Squibb
03.2022 - 04.2023
  • Raw Materials and water testing (TOC, ACM, FTIR, UV, KF, autotitrator, osmometer, polarimeter, HPLC and UPLC)
  • Authoring, review, and approval of QC documentation
  • Management / storage of QC documentation to align with GDP principles
  • Experienced with laboratory investigations, deviations and CAPAs
  • Active role in tech transfers and validations including testing and developing procedures
  • Training in new colleagues
  • Experience with trouble shooting equipment during tech transfers and validations
  • Audit preparation, audit walkdowns and presentation to auditors
  • Experience with the hiring process for new interns including CV selection and interviewing
  • People manager for the QC Raw Materials Intern
  • Active role in the University Relations team in BMS.

QC Raw Materials Specialist

Bristol-Myers Squibb
09.2019 - 03.2022
  • Conducted testing for Validations / Technical Transfers on site
  • Key role in a co-validation project for UV-Vis Spectrometry with BMS Devens
  • Investigating low and medium level Laboratory Investigations, Deviations and Out of Specification results using Trackwise and Infinity systems
  • Performing routine water testing including TOC, Conductivity, Nitrates & Chlorine analysis
  • Performing routine Raw Materials testing
  • Audit preparation readiness for HPRA and FDA audits
  • Involvement in the 5S project for the Raw Materials laboratory
  • Training in new colleagues on various laboratory testing techniques and systems
  • Generating, updating, reviewing, and approving QC documents.

QC Analytical Services (Trending) Intern

Bristol-Myers Squibb
01.2018 - 09.2018
  • Receipt and reconciliation of samples using LIMS and CIMS
  • Trending of analytical data
  • Involvement in audit preparation readiness for an FDA audit
  • Weekly forecasting of samples arriving to BMS sent out site wide
  • Conducted a weekly global oversight of the testing status of multiple drug product batches
  • This was sent to a senior leadership audience and highlighted the risk to drug product market supply
  • Authoring and updating GMP documents for QC.

Education

Master of Science - Pharmaceutical Validation Technology

Technological University Dublin
01.2024

Bachelor of Science - Genetics and Cell Biology

Dublin City University
05.2019

Skills

  • GMP/GDP principles
  • Strong Communication
  • Presentation Skills
  • Validation
  • People Management
  • Auditing
  • Lead Investigator
  • OpEx - Yellow Belt Certified
  • Trained Lean Practitioner
  • Analytical Testing
  • Microsoft Office
  • Visio

Systems

  • Trackwise / Veeva Vault
  • LES
  • CIMS / LIMS
  • EMPOWER
  • SAP
  • Delta V

Testing Equipment

  • FTIR
  • KF
  • UV-VIS
  • HPLC / UPLC
  • AUTOTITRATION
  • ACM
  • TOC
  • OSMOMETER
  • PH METER
  • POLARIMETER

References

  • Amanda Corcoran, Quality Analytical Senior Manager at BMS, Amanda.Corcoran@bms.com
  • Ann-Marie Noone, QC Senior Manager at BMS, Ann-Marie.Noone@bms.com

Timeline

QC Raw Materials Technical Lead

Bristol-Myers Squibb
04.2023 - 03.2024

QC Senior Specialist Raw Materials

Bristol-Myers Squibb
03.2022 - 04.2023

QC Raw Materials Specialist

Bristol-Myers Squibb
09.2019 - 03.2022

QC Analytical Services (Trending) Intern

Bristol-Myers Squibb
01.2018 - 09.2018

Master of Science - Pharmaceutical Validation Technology

Technological University Dublin

Bachelor of Science - Genetics and Cell Biology

Dublin City University

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