Whitby, Ontario, Canada
Quality professional with 10+ years of experience in regulated environments, now applying my skills to medical device and organ preservation technology at Traferox. My focus is on compliance, quality systems, and patient safety. All of which are values that have guided me across food, biopharma, and health care.
· Supporting quality assurance activities for organ preservation and transplantation technologies. · Contributing to the maintenance and improvement of the Quality Management System (QMS) in a regulated medical device environment. · Collaborating with cross-functional teams to ensure compliance with GMP and regulatory standards. · Committed to advancing the company's mission of increasing donor organ availability and saving lives.
· Acted as the quality guardian for all processes on shift, ensuring compliance with allergen sign‑offs, sanitation protocols, CCP checks (HACCP), and GMP standards. · Used SAP S/4HANA to maintain accurate quality records, track compliance metrics, and support internal and external audit readiness. · Performed routine inspections on production lines, identifying quality deviations and supporting real‑time corrective actions. · Troubleshot quality issues on the production floor, collaborating with operations teams to resolve root causes and prevent recurrence. · Conducted environmental and product swabbing (ATP, PCS, allergen) to verify sanitation effectiveness and ensure product safety. · Led investigations into food safety holds, customer complaints, and near misses, conducting root cause analysis, risk assessments, and ensuring timely closure. · Delivered quality and food safety training to shift teams, ensuring audit compliance and team competency.
•Heavily involved with the management of the Training within the business's QMS • Assist with maintenance of externally facing quality management system, including materials management, vendor management, audits (internal, external, and 3rd party), and quality support for client projects. • Review of deviation investigations and change controls and implementation of corrective and preventative actions. • Assist with the maintenance of the ISO 9001 Quality Management System. • Provide support with the supplier audit program to support GMP operations. • Support and participate in audits by clients and regulatory authorities. • Assist end-users of the electronic QMS to provide training on use of quality systems, system maintenance, and other quality procedures. • Work with team members to develop, draft, and review specific documents (SOPs, specifications, etc.) in accordance with GMP regulations. • Interface with academic and industry partners to ensure meaningful engagement and collaboration.
• Assist with maintenance of externally facing quality management system, including materials management, vendor management, audits (internal, external, and 3rd party), and quality support for client projects. • Review of deviation investigations and change controls and implementation of corrective and preventative actions. • Assist with the maintenance of the ISO 9001 Quality Management System. • Provide support with the supplier audit program to support GMP operations. • Support and participate in audits by clients and regulatory authorities. • Assist end-users of the electronic QMS to provide training on use of quality systems, system maintenance, and other quality procedures. • Work with team members to develop, draft, and review specific documents (SOPs, specifications, etc.) in accordance with GMP regulations. • Interface with academic and industry partners to ensure meaningful engagement and collaboration.
• Responsible to ensure that the controlled Grade A and B manufacturing areas are clean and remain in a state of control. • Assist client in manufacturing cell and gene therapies. • Familiar with Change Controls and how to use the QMS MasterControl. • Presents updates to team and clients and provides technical expertise in team/client meetings. • Collaborates with cross-functional teams (Operations, Compliance, QA/QC, SA and Facilities) to manufacture and deliver products to clients on schedule. • Lead team for scheduling, training new team members.
• Enter accurate data into ECancer Care Database in regards to patient data and charts in a timely manner • Responsible for managing lab equipment by overseeing logistical needs by shipping and receiving as needed. • Picking up and dropping off products and supplies on short notice throughout the facility • Independently oversee the lab’s Cell Disposal project in regards to expired patient’s cells • Working with confidential and private information on a daily basis • Responsible for monitoring the lab on a regular basis to ensure equipment and processes are running up to regulated standards while multitasking. • Validate new equipment and ensure it meets current standards as prescribed under the Occupational Health and Safety Act • Ensure Cryogenic LN2 tanks are operating in a safe manner
• Able to process patient's blood samples to harvest PBMC's for multiple studies • Daily cleaning and maintenance of the lab area and biosafety cabinets • Capable of transferring cells from -80°C to liquid nitrogen for storage • Efficient at mapping and tracking of multiple patient samples with in various databases • Perform DNA and RNA extractions as needed
• Familiar with the process of mixing and blending of pharmaceutical products • Ability to clean rooms with proper detergents in compliance with companies SOPs • Knowledge on filling out batch records and paperwork as needed • Proficient at collecting samples of pharmaceutical products for analysis