Julie Lees
Principal Quality Specialist @Sequoia Biotech Consulting
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WORK HISTORY
Principal Quality Specialist @Sequoia Biotech Consulting
San Diego, CA, US
Current: Clean-in-Place (CIP), Clean out of Place (COP) gap assessments, Cleaning validation. Recent: ISO 13485:2016 audit prep, audit response and CAPA execution and management.
EDUCATION
University of Minnesota
B.A., Liberal Arts: Studio Arts, Music
University of Nebraska-Lincoln
Music Education
San Diego Mesa College
Certification, Building Construction Technology
Metropolitan State University of Denver
B.A., Chemistry
ABOUT JULIE LEES
I am a Quality Assurance professional with GMP biotech experience. My broad knowledge has been gained from over 22 years as an industry validation consultant, and an FTE Quality Assurance validation manager. I drive effective communication between cross-functional teams to facilitate delivery of quality products. My expertise is in Clean-In-Place (CIP) and Clean-Out-of-Place (COP) systems, autoclave qualification, Change Control, and CAPA administration. I am able to provide internal and external audit support with a focus on gap analysis and system improvements.
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