Experience

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  Precision NanoSystems Inc.

  • Vancouver, British Columbia, Canada

  • Quality Assurance Specialist

    • Nov 2023 - Present
    • Vancouver, British Columbia, Canada

    -Participates in the implementation of an electronic Quality Management System (eQMS) for various quality modules.-Performs gap assessments and develops site-level procedures and work instructions to meet global GMP requirements and corporate quality policies.-Acts as eQMS administrator.-Develops and provides training for the organization and users of the quality systems and electronic tools.-Leads or participates in investigations into deviations or other quality events, with a focus on root cause analysis and continuous improvement.-Analyzes system data and prepares reports on quality systems performance for key stakeholders.-Participate in internal audits as a subject matter expert.-Participate in customer audits and regulatory inspections as a SME.

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  Cytiva

  • Burnaby, British Columbia

  • Quality Assurance Associate

    • Aug 2021 - Jul 2023
    • Burnaby, British Columbia

    - Support of the Quality Management System; Deviations, CAPA, Change Requests and other modules- Review and approve QMS deviations and investigations- Follow-up/Assist with CAPAs and Change Requests- Perform internal audits, assist with external audits (2nd party and external clients)- Maintain staff training records and associated programs- Write, revise and review SOPs; procedures from both Quality and other departments- Track KPIs and report to management, as applicable- Drive continual improvement, with participation in kaizen and PSP events

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  Evonik

  • Burnaby, British Columbia

  • Senior Quality Assurance Specialist

    • Jan 2019 - Aug 2021
    • Burnaby, British Columbia

    - Review and approve Analytical Reports and associated Raw Data- Provide input into preparation and review of Drug Product and Raw Material Specs- Review, approve and revise SOPs- Review and approve Master Batch Records- Disposition of Raw Materials and supplies for drug manufacturing- Perform Line Clearance of the GMP Suite- Participate in the Environmental Monitoring program- Review equipment qualification reports - Conduct internal audits- Assist in new employee orientations- Assist and participate in company-wide GMP training- Participate in process simulations to support GMP manufacturing

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  Cardiome / Correvio Pharma Corp

  • Vancouver, British Columbia

  • Quality Assurance Coordinator

    • 2017 - 2019
    • Vancouver, British Columbia

    • Coordinate Global Change Controls, CAPAs and Deviations related to Infusion Bag and Vial Products: - Process all incoming notifications and change requests from CMOs, distributors and internal departments- Route appropriate forms to SMEs for Review, Input and/or Impact Assessment and Approval - Monitor the progress of documents and action items and provide status updates at weekly cross functional meetings- Liaise with CMOs and internal departments for completion of tasks and supporting documentation- Compile and assemble documents for Closure• Investigate Market and Supply Chain Complaints:- Correspond with complainants (acknowledgement and request of additional information). - Instigate and collaborate with CMOs/ distributors for investigations, compile documentation and compose complaint memos upon investigation closure- Report monthly complaints metrics to senior management • Perform QA Reviews for Regulatory submissions, New Drug Submissions and Investigators Brochure

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  New β Innovation Ltd

  • Burnaby, British Columbia

  • Quality Assurance Associate

    • 2015 - 2017
    • Burnaby, British Columbia

    Through translating medical sciences into applicable health solutions, New ß Innovation is committed to develop safe and effective oxygen therapeutics in compliance with international quality standards (Europe, Canada, US). Our breakthrough technology is the driving force towards our successful development of treatment solutions for life-saving and health enhancement.As a member of the QA Department, I am contributing for the development and implementation of the Quality Management System for a state-of-the-art sterile biopharmaceutical manufacturing facility. The facility is targeted to meet regulatory and compliance requirements as set forth in Health Canada GMPs, USFDA cGMP and EU regulations for aseptic processing.

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  Sandoz Canada

  • Boucherville, Québec

  • Microbiology Analyst

    • 2011 - 2014
    • Boucherville, Québec

    Joined Sandoz after completing AEC qualification as first job in Canadian market and contributed strongly to a major FDA remediation project (“Laboratory Excellence”) in the quality control team which successfully implemented 5S standards in the laboratory and enabling rhythm wheel protocols for prioritizing testing and management of samples received from the production and post-production cycles.

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  Bio-Manguinhos / Fiocruz

  • Rio de Janeiro Area, Brazil

  • Biotechnologist

    • 2005 - 2009
    • Rio de Janeiro Area, Brazil

    Acted as point of contact between Quality Control and Quality Assurance / Regulatory Affairs and prepared reports and records for WHO and NRA – ANVISA (Brazilian national health regulators). Participated in technology transfer projects from GSK-Belgium and CIGB/CIM-Cuba, translating SOPs and other technical documents, developing and maintaining standards, designing sampling plans, adapting and implementing new QC techniques and supporting stringent biochemical and molecular biology quality control processes in the microbiological control laboratory by compiling records and interpreting experimental or analytical results from samples.

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  Central Laboratory of Rio de Janeiro State Noel Nutels

  • Rio de Janeiro Area, Brazil

  • Laboratory Technician

    • 1998 - 1999
    • Rio de Janeiro Area, Brazil

    Participated in a very large high-throughput analysis of blood samples for Brazilian Armed Forces members in order to detect incidences of HIV; this was a major government research project and with strong collaboration from the whole team, it was accomplished within the agreed time frames and protocols.