Cody Ganz Email & Phone Number

Eagan, Minnesota, United States

• 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

Eagan, Minnesota, United States

• Responsible for quality oversight of the equipment calibration, equipment qualification and CSV programs
• Host external client audits
• Oversee risk management and CAPA program, working closely with and mentoring CAPA owners
• Review and trend deviations
• Same QA Specialist responsibilities as below

Eagan, MN

• Review study documentation including raw data, SOPs, protocols and reported results to ensure compliance. In 2020, on a team of 4, reviewed 37% of study reports (656) with a first time right (FTR) of 99.6%. In 2021.
• Perform in-process audits of laboratory testing
• Perform internal audits of each department within the facility
• Use electronic system to write and review controlled documents
• Responsible for new employee onboarding, including GLP training

Madison, Wisconsin Area

• Wrote and executed IQ, OQ, and PQ validation protocols
• Scheduled and prioritized validation projects for all groups across the site including Analytical Development, Facilities, Manufacturing and Quality Control
• Responsible for all change control activities required for equipment activation
• Served as primary resource for Computer System Validation (CSV)
• Created and validated spreadsheets for GMP use
• Performed requalifications and calibrations using the Kaye Validator and Kaye Validator Report Wizard

Madison, Wisconsin Area

• Drafted and edited SOPs
• Significant data review including validation protocols, assay qualification protocols, stability data and batch records
• Conducted cGMP audits for compliance in areas such as manufacturing, maintenance and calibration, laboratory practices, SOPs, document control and training
• Utilized quality systems including change control, deviation and correction to ensure the site remained in a state of compliance
• Maintained quality metrics and trending data

Madison, Wisconsin Area

• Gained valuable experience working in a professional GMP setting
• Followed SOPs to properly clean glassware and sintered glass funnels (and confirm cleanliness via thin-layer chromatography), as well as prepare numerous solutions for use in labs
• Learned proper lab maintenance
• Worked closely with chemists as a Secondary Operator, assisting them wherever necessary