QA Specialist

About the Role

Work with internal manufacturing colleagues as a cross-functional member and approver of Zoetis investigations. Participate in production lab walk-through audits prior to and post construction projects, as well as ongoing maintenance activities requiring Quality oversight. Provide manufacturing floor support as needed to maintain compliance with local policies and procedures. Review and approve Environmental and manufacturing investigations and reports. Support regulatory inspections and follow-up action items. Perform product-related system dispositions as necessary based on local site procedures. Review batch records and other records relating to processing of components, materials, and finished veterinary biologicals for comparison with approved specifications and regulatory requirements to support timely product release.

Responsibilities

• Actively support, review, and approve all manufacturing/environmental/GMP deviations and related items (Visual mapping boards, action items, commitments tracking, etc.) related to the manufacture of veterinary biological products at the Charles City, Iowa facility.
• Conduct walk-through audits as part of the paint and patch process, as well as ongoing construction activities. Audits may include pre- and post-reviews and various system verifications.
• Perform product-related SAP system dispositions based on local site procedures.
• Participate in the Change Management process as a Quality Subject Matter Expert (SME).
• Participate in the preparation for and execution of regulatory agency inspections.
• Develop, revise, implement, and maintain assigned Quality Assurance standard operating procedures to ensure compliance with regulatory and quality standards requirements.
• Perform batch record reviews and reviews of other records relating to the processing of components, materials, and finished veterinary biologicals for comparison with approved specifications and regulatory requirements to support timely product release.
• Audit manufacturing processes for compliance against internal and regulatory filings (ZQS, PP, EU dossier, other markets).

Requirements

• Associate: BA/BS with 0-2 years of experience OR minimum of 6 years relevant experience.
• Specialist: BA/BS with 2-4 years of experience OR minimum of 8 years relevant experience.
• Training in CAPA, Analytical Problem Solving, and Root Cause Analysis preferred.
• Excellent verbal and written communication skills; fluent in English.
• Proficient with SAP, Word, Excel, and PowerPoint.
• Excellent organizational skills and strong ability to multi-task.
• Willingness to positively embrace change and flexibility in adjusting to shifting priorities.
• Strong attention to detail, ability to work well independently and as part of a team, and to work effectively with people at all levels within the organization.
• Travel may be required.

About Zoetis

At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture, and commercialize vaccines, medicines, diagnostics, and other technologies for companion animals and livestock. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection, and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies, and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.