Experience

Ozmosis Research Inc.

• Canada
• Research Services
• 1 - 100 Employee

• Quality Assurance & Regulatory Affairs Specialist

  • Apr 2022 - Present

  • Prepared regulatory submissions to Health Canada and responded to clarification requests within the required timelines• Developed an organized tracking system and checklist process for regulatory affairs• Interviewed external personnel and set up questionnaires for vendor audits and site audits• Leveraged the Medidata and REDCap databases to review data for discrepancies• Led document development and staff training for eTMF management• Mentored new staff through the conduct of internal audits and quality control reviews Show less

• Quality Assurance Specialist

  • Nov 2020 - Apr 2022

  • Audited Trial Master Files and internal tracking tools to ensure compliance with company procedures, ICH-GCP guidelines and applicable regulations • Generated reports to communicate and follow up on findings from internal audits, quality control reviews and vendor audits• Reviewed protocols, informed consent forms and product labels for adherence to ICH-GCP guidelines and applicable regulations• Analysed audit finding and standard operating procedures (SOP) deviation metrics to create annual quality assurance and quality control schedules• Managed documentation and process related to the creation/revision, approvals and training of SOPs and controlled documents Show less



School of Tae Kwon Do & Martial Arts

• Canada
• Wellness and Fitness Services

• Key Holder & Instructor

  • Sep 2015 - Sep 2019

  • Facilitated the teaching of various techniques and patterns • Evaluated the ability of students through testing • Established goals and standards for students to accomplish • Involved in marketing campaigns • Participated in meetings to discuss areas of improvement for the school • Facilitated the teaching of various techniques and patterns • Evaluated the ability of students through testing • Established goals and standards for students to accomplish • Involved in marketing campaigns • Participated in meetings to discuss areas of improvement for the school



Sanofi Pasteur

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Formulations Co-Op Student

  • Sep 2018 - Aug 2019

  • Drafted and revised standard operating procedures to support CCRs and CAPAs • Gathered and analyzed data for the completion of deviation reports • Performed technical writing for production deviation reports • Maintained the workspace to ensure that cGMP standards were met • Supported validation and process improvement projects • Utilized SAP to check the status of equipment and work orders • Ensured chemicals were stored and documented to meet WHMIS standards • Drafted and revised standard operating procedures to support CCRs and CAPAs • Gathered and analyzed data for the completion of deviation reports • Performed technical writing for production deviation reports • Maintained the workspace to ensure that cGMP standards were met • Supported validation and process improvement projects • Utilized SAP to check the status of equipment and work orders • Ensured chemicals were stored and documented to meet WHMIS standards



Sunnybrook Research Institute

• Research Student

  • May 2018 - Aug 2018

  • Conducted a meta-analysis to compare C1-INH levels of Alzheimer’s patients and healthy control groups • Created a poster presentation to illustrate the results of a meta-analysis • Conducted a meta-analysis to compare C1-INH levels of Alzheimer’s patients and healthy control groups • Created a poster presentation to illustrate the results of a meta-analysis



Dafco Filtration Group

• Production Operator

  • May 2017 - Aug 2017

  • Operated assembly line machinery and ensured that the quota for products was met • Trained new operators on the best practice techniques and equipment safety • Coordinated with packagers to ensure that quality standards were met • Operated assembly line machinery and ensured that the quota for products was met • Trained new operators on the best practice techniques and equipment safety • Coordinated with packagers to ensure that quality standards were met