Quality Inspection & Audit Specialist

Zoetis•Lincoln, NE

4d•Onsite

About The Position

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.

Requirements

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.
Strong quality orientation and attention to detail.
Deep working knowledge of cGMPs (pharmaceuticals and vaccines) and GMP auditing in biological/pharma industries.
Expertise in quality systems, data integrity, and software compliance.
Excellent analytical skills: ability to assess and resolve complex compliance situations.
Demonstrated problem-solving skills and ability to reach data-driven conclusions.
Exceptional communication skills (written and oral), with persuasive presentation ability; effective cross-functional and supplier interfacing.
Proven ability to work independently and manage multiple projects concurrently.
Proven leadership of high-visibility, multi-disciplinary investigations and projects.
Extensive experience with Excel and PowerPoint.
Proficiency in English.
Must be able to work on-site at the Zoetis Lincoln Manufacturing Site on a regular basis.
Ability to walk throughout the manufacturing facility, attend in-person meetings, and observe processes as needed.
Must be able to sit or stand for extended periods during meetings or audit activities.
Ability to wear appropriate personal protective equipment (PPE) when accessing manufacturing or laboratory areas.

Nice To Haves

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).
Prior involvement in material or supplier qualification, change control, or quality assurance processes is a plus.

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.