Work experience

• Quality Assurance Specialist

  Augurex Life Sciences Corp.

  2024.11-Current

  (a year)
• QA Compliance Coordinator

  New Beta Innovation Canada Limited

  2024.01-Current

  (2 years)

  (1 year 10 months)
• Quality Assurance Specialist

  New Beta Innovation Canada Limited

  2022.06-2023.10

  (a year)

  (1 year 5 months) Review QMS documents such as but not limited to deviations, CAPA’s, Investigations, change controls, alarms, excursions, etc. Review GMP documents including but not limited to sop’s, batch records, qualifications protocols, studies, reports, etc. Create and revise QMS SOP’s as required. Perform document control activities such as but not limited to issuance, reconciliation, archival, number assignment and formatting of GMP documents. Performing routine training coordinator duties and support in improvement of company’s GMP training program. Perform routine line clearance checks and QA oversight on manufacturing, aseptic filling and packaging functions. Ensure regular GMP compliance on the production floor. Prepare and review media fill, process validation, and cleaning validation documentation and provide oversight as required. Perform data collection and development of statistics for monthly and quarterly management review meetings. Participate in internal and external audit activities as assigned. Collaborate and work closely with all departments to maintain quality culture.
• Quality Systems Specialist

  The Janssen Pharmaceutical Companies of Johnson & Johnson

  2021.05-2022.07

  (a year)

  2 years 11 months (1 year 3 months) I was part of the Quality Systems team in Janssen. I provided support and guidance to users on the Event & Deviation and CAPA process, I also provided guidance and support on the Quality Event Management module located in the Trackwise system which is used across both sites in Cork. I generated multi- site weekly quality metrics which were then reported to all employees. I hosted induction training on GMP for inductees joining Janssen, I also hosted training on the Quality Event Management system for all users. I trained and mentored users on various Quality Systems. I created, updated, reviewed and approved documentation as required through our electronic documentation management system. I prepared lists of pre-req’s and defended the Event & Deviation and CAPA Process during regulatory audits.
• Quality Systems Documentation Specialist

  The Janssen Pharmaceutical Companies of Johnson & Johnson

  2020.04-2021.05

  (a year)

  (1 year 2 months) Working as part of the Quality Systems team in Janssen. I provided support and guidance to users on the electronic document management system used across both sites in Cork. I generated multi-site weekly quality metrics which are then reported to all employees. I hosted training on Good Documentation Practices for inductees joining Janssen. I trained and mentored users on various Quality Systems. I created, updated, reviewed and approved documentation as required through our electronic documentation management system. I assisted and helped prepare for regulatory audits as required.
• Quality Systems Documentation Specialist

  The Janssen Pharmaceutical Companies of Johnson & Johnson

  2019.09-2020.04

  (8 months)

  I was part of the Quality Systems project team on BioCork2. Mainly dealing with engineering documentation handover support and logistics. This documentation was essential as incompletion of this documentation would hold up commissioning and qualification. This documentation ensures regulatory compliance of the equipment. I also supported the engineering documentation turnover schedule with PM, Sisk and the construction team. I performed final review of documentation from a GDP standpoint. Project storage, retrieval and archival and transition to JSI format was then completed by us. I also liaised with PM and Sisk documentation control regularly. I also presented weekly metrics to the construction quality lead to reach goals towards project completion.
• Technical Operations

  The Janssen Pharmaceutical Companies of Johnson & Johnson

  2018.03-2018.09

  (7 months)

  -Cleaning and process validation. -Review, approval and updating of relevant documentation. -Implemented 5S methodologies for cleaning items onsite. -Analysing cleaning data to reduce cleaning cycle times. -Created and implemented cleaning process boards for each piece of manufacturing equipment onsite.

Educational experience

• Cork Institute of Technology

  Pharmaceutical Biotechnology, Biotechnology

  2015.01-2019.01

  (4 years)

Certificates