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 ● 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

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, reviewed 564 reports with a FTR of 100%.• 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• Provided statistical support for Quality Systems monitoring and review• Served as the purchasing Subject Matter Expert (SME) for the quality group

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