Cody Ganz

Quality Assurance Manager @Element Materials Technology

Minneapolis, MN, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Feb 2022 — Present

Quality Assurance Manager @Element Materials Technology

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Eagan, MN, US

Lead the Quality Assurance program, manage daily QA activities for the department, and evaluate the performance of QA staff consisting of up to seven direct reports Ensure the site operates in accordance to applicable GLP (40 CFR Part 160 and 21 CFR Part 58) regulations and guidance Host regulatory inspections Lead the site to receive its ISO 17025 accreditation in 2023 Implemented an eQMS for completion of CAPA, deviation, and out of specification investigations Maintain effective relationships both internally and externally to deliver high quality service Collect, trend and analyze quality metric trending data, and report to management on a routine basis Approve change controls for validated systems Oversee supplier qualification program Ensure customer complaints are thoroughly investigated Utilize Lean and 5S for continuous improvement Manage and perform all other QA procedures shown below on an as-needed basis

EDUCATION

2009 — 2013

University of Wisconsin-Madison

Bachelor's Degree, Biochemistry

SKILLS

FdaQuality ControlGmpQuality SystemCapaGlp21 Cfr Part 11GxpQuality AuditingAseptic ProcessingValidationBiochemistryLife SciencesBiotechnologyChange ControlQuality AssuranceSop

ABOUT CODY GANZ

Quality professional with 10+ years of experience working in regulated laboratory environments. Laboratory and quality background with excellent quality system, client service, project management, and people leadership skills. Experience with both GLP and GMP regulations. Additional expertise includes: collaborating with SMEs, validation principles, and data review.

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