Will Lin
Quality Assurance Compliance Specialist @Tk Modular
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WORK HISTORY
Quality Assurance Compliance Specialist @Tk Modular
ISO 9001 Implementation and MaintenanceParticipate, implement, and maintain ISO 9001 quality management systems, ensuring compliance with the standard throughout the organization.· ASME Standards Implementation and MaintenanceParticipate, implement, and maintain ASME Standards quality management systems, ensuring compliance with the standard throughout the organization.· Quality Systems ManagementSupport the development and improvement of the QMS, including SOP creation, revision, and enforcement.· Compliance AuditsParticipate in internal and external audits, ensuring the company is in compliance with ISO 9001, ASME B31.3, ASME BPE, ASME div 1, and other relevant standards. Prepare and present audit findings and follow through on corrective actions.· Documentation ControlMaintain and update quality documentation, including but not limited to technical specifications, compliance reports, and SOPs. Ensure all documents meet company and regulatory standards.· Continuous Improvement InitiativesIdentify opportunities for process improvements and work with cross-functional teams to implement effective solutions. Lead initiatives that drive process efficiency and cost savings while ensuring compliance.o Risk ManagementConduct risk assessments and implement controls to mitigate potential quality and compliance risks. o Training and DevelopmentAssist in developing and delivering quality and compliance training programs to ensure all employees are knowledgeable about QMS processes and regulatory standards.o Supplier and Vendor AuditsAssist and conduct quality and compliance assessments of key suppliers and vendors to ensure they meet internal and external standards for pharmaceutical and biopharmaceutical equipment.o Root Cause Analysis and CAPA· Cost of Poor Quality (COPQ)
EDUCATION
University of Toronto
Specialist in Chemistry, Minor in Economics , Chemistry
Seneca Polytechnic
Postgraduate Certificate, Pharmaceutical Regulatory Affairs and Quality Operations
ABOUT WILL LIN
Currently an QA/RA associate. Coming from a background of a Chemistry Specialist from the University of Toronto and a post-grad certificate from Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College.
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