Quality Inspection & Audit Specialist

Zoetis is the world’s largest Manufacturer and Supplier of Animal Pharmaceuticals.

At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska’s Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow.

Benefits Include:

4 weeks accrued paid vacation and 13 paid holidays.

401(k) match with company profit sharing.

Tuition reimbursement and Student Loan repayment program.

Great Health, personal, and family benefits starting day 1.

Position Summary

The Quality Inspection and Audit Specialist supports Lincoln Operations in maintaining compliance with global regulatory requirements across Zoetis markets. The role leads alignment to evolving Board of Health regulations, identifies regulatory gaps, and partners with site leadership and SMEs to develop and implement strategic closure plans. Responsibilities include planning and conducting internal audits, assessing CAPA effectiveness, and providing strategy and subject matter expertise before, during, and after regulatory inspections. The specialist also oversees supplier quality activities, including audits, complaints, and quality agreements, and coordinates the annual review of global and site standards. This role requires strong quality systems, data integrity, software compliance, and cGMP expertise. Occasional travel is required.

Hours: 1st Shift, 8:00am – 4:30pm. Evening and weekend support based on business needs.

Position Responsibilities

• Regulatory Alignment and Strategy
• Monitor and support alignment with new and changing Board of Health regulations across global markets; plan alignment strategy, report status to site and Zoetis leadership, and manage implementation with subject matter experts (SMEs) .
• Stay current on regulations and guidelines: USDA, FDA, EU, PIC/S, Russia, Turkey, and other emerging markets.
• Provide inspection readiness strategy and subject matter expertise pre-, during, and post-inspection.
• Gap Assessment and CAPA
• Support gap assessments for regulatory inspection findings and market changes; identify and manage CAPA to closure in partnership with SMEs and market regulatory.
• Perform effectiveness checks to verify CAPA outcomes and sustained compliance.
• Internal Auditing
• Conduct internal quality audits leveraging expertise in quality systems, data integrity, software compliance, and GMP requirements.
• Write audit reports with clear findings, significance, and actionable items.
• Supplier Qualification & Management
• Plan and execute risk-based supplier audits; document findings and drive CAPAs.
• Qualify new suppliers and maintain the Approved Supplier List; draft/review Quality Agreements.
• Manage ongoing supplier performance, including change notifications, risk assessments, and periodic reviews.
• Lead/support the Supplier Complaint Process to timely closure (investigation, RCA, CAPA, effectiveness checks).
• Collaborate cross-functionally to ensure GxP compliance and maintain audit-ready records and metrics.
• Standards and Continuous Improvement
• Review and assess Global Standards and Site Standards in collaboration with SMEs.
• Promote continual improvement in auditing and inspection systems.
• Maintain current knowledge of company policies, industry standards, and government regulations.
• Travel
• Occasional travel required.

Education and Experience

• Required
• Bachelor’s degree in engineering, science, or related field; or equivalent experience.
• At least 10 years of related experience in Quality Assurance or sterile/non-sterile manufacturing.
• At least 5 years of project management leading multi-disciplinary teams.
• 2–4 years of experience applying regulations and communicating with regulatory agencies in the Animal Health/Pharma industry.
• Familiarity with USDA, FDA, EU, and relevant foreign regulatory laws.
• Prior involvement in material or supplier qualification, change control, or quality assurance processes is a plus.
• Preferred
• 4+ years of experience applying regulations and communicating with regulatory agencies in the Animal Health/Pharma industry, including conducting internal and external (supplier/contract service) audits and assessments.
• Advanced degree or auditing certification/training (e.g., ISO, ASQ, RQA).

Technical Skills and Competencies Required

• Strong quality orientation and attention to detail.
• Deep working knowledge of cGMPs (pharmaceuticals and vaccines)