Aoife McCormack

· Coordinating Technical transfers, Verifications and Validations for Raw Materials in the QC laboratory and Contract test laboratories.

· Determining the weekly testing schedule for the QC Raw Materials laboratory.

· Conducting audit walk downs to ensure GMP / GLP.

· 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.

· Providing technical expertise for methods and equipment.

· Involvement in qualification of new equipment (approver of URS, DQ, IOQ and PQ documentation).

· Lead a lean practitioner project which increased the testing time frame of water samples within the Raw Materials laboratory.

· Involvement in Material Qualification

· Review and approval of quality investigations / deviations.

· Experience with change controls as a change owner, completing impact assessments and change actions.

· Experienced with laboratory investigations, deviations and CAPAs.

· Investigation Champion, this includes assisting colleagues with their investigations, tracking QMS records and ensuring metrics are met.

· Active role in tech transfers and validations including testing and developing procedures.

· Experience with trouble shooting equipment during tech transfers and validations.

· An SME for various equipment including FTIR, UV, KF and autotitrator.

· Raw Materials and water testing experience with laboratory equipment such as TOC, ACM, FTIR, UV, KF, autotitrator, osmometer, polarimeter, HPLC and UPLC.

· Experienced in audit preparation, audit walkdowns and presentation to auditors.

· Proficient in the use of Tiamo, MODA, LIMS, CIMS, LES, Empower, Trackwise and Infinty.

· 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.

· Involvement in the PQ for a KF instrument including protocol execution and authoring the PQ summary report.

· Completed a yellow belt certification project which changed the process whereby the information for Raw Materials was viewed and updated. This project reduced the workload of 6 departments across BMS and reduced errors within the process.

· Conducted testing for 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.

· Receipt and reconciliation of samples using LIMS and CIMS.

· 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 QCTS.