Quality Control Manager
Zoetis · Charles City, Iowa, US
Position Summary: Manages all Biological Quality Control Operations for the Charles City site to ensure all vaccines meet US, EU and International regulatory...
Job description
Position Summary: Manages all Biological Quality Control Operations for the Charles City site to ensure all vaccines meet US, EU and International regulatory requirements. Advise Management of products not meeting required testing specifications and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements. Position Responsibilities: - Oversee day to day activities in the Quality Control laboratories and Animal Test facility. Manages 4 departments within the Quality Control Organization, Virology; Bacteriology and Immunology; Chemistry, Microbiology and Environmental Monitoring; and Animal Test. - Assures overall quality/integrity of biological products manufactured and distributed in worldwide markets based on 9CFR, applicable cGMP regulations (EU, JP, etc.), and industry standards. - Ensure all biological products manufactured by or distributed by Charles City are tested according to applicable USDA, EU and Zoetis quality standards, as well as the regulatory requirements of a destination country. - Responsible for APHIS sampling, APHIS Form 2008 preparation, Stability and Confirmation of Expiry Testing and submissions, LIMS management an...