Quality Inspection & Audit Specialist

Zoetis is the worlds 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 Nebraskas 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
• Bachelors 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.
• 24 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) 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.

Physical Position Requirements

Physical & Onsite Requirements

• 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.
• May require occasional work outside of normal work schedule to meet critical deadlines or support site inspections.

Occasional travel required.

Full time

Regular

Colleague

Any unsolicited resumes sent to Zoetis from a third party such as an Agency recruiter including unsolicited resumes sent to a Zoetis mailing address fax machine or email address directly to Zoetis employees or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

Notice: Zoetis Recruiters will contact candidates via email from an address ending in @ and may also initially connect with candidates through LinkedIn including LinkedIn InMail. Zoetis does not use Gmail Outlook Yahoo or other web-based/generic email domains to communicate about job opportunities interviews or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @ please treat it as suspicious. For your security do not reply click links open attachments share personal or financial information or send money in response to unexpected or questionable recruitment communications.

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at to request an accommodation. Zoetis also complies with all applicable national state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at site or (2) via email to/from addresses using only the Zoetis domain of @. In addition Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be addition Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.