Sherry Kim
Quality Assurance Manager @Nusano
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WORK HISTORY
Quality Assurance Manager @Nusano
Valencia, CA, US
Development and Implementation of a Quality Management System following NQA-1, ICH Q7, 21 CFR Part 11, ISO 9001:2015 regulatory requirements in a Start-Up Environment Development and Implementation of an Employee Training Program including employee onboarding process Implementation and Validation and Rollout of eQMS system (IQVIA SmartSolve) Development and Implementation of Supplier Approval Process, including procedures for Supplier Management Collaboration with all departments in creation of SOPs, Procedures and Work Instructions Development and Implementation of NC and CAPA programs Manage Document Control and Supplier Approval via Change Control Board and Quality Review Board
EDUCATION
UC Santa Barbara
Bachelor of Science (B.S.), Molecular, Cellular and Developmental Biology
UC Santa Barbara
Bachelor of Arts (B.A.), Asian-American Studies
SKILLS
ABOUT SHERRY KIM
As a Quality Assurance Manager with over five years at Nusano, expertise lies in developing and implementing robust quality management systems tailored to regulatory frameworks such as ICH Q7 and ISO 9001:2015. The role emphasizes cross-functional collaboration for SOP creation, supplier management, and employee training programs, alongside spearheading eQMS system validation and rollout. With a mission to ensure compliance and operational efficiency in the biotech industry, efforts have been pivotal in establishing non-conformance and CAPA programs, managing document control, and facilitating quality reviews. Values are grounded in fostering organizational alignment with industry standards while driving continuous improvement across processes and teams.
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