Compliance Specialist - Reference Qualification

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

Perform activities necessary maintain the Reference Qualification Program, ensuring compliance with USDA and GMP regulations, Global Quality Standards, and other applicable regulations, as well as site policies and procedures.

This position also provides Quality Assurance (QA) support for the Lincoln Quality Control laboratories. This position is responsible for providing on-the-floor QA support functions for quality control operations by performing laboratory investigation review, quality assessments, deviation decisions and managing Change Control up to 50% of time.

Hours : 1st Shift, Monday - Friday.

Position Responsibilities

• Assist with or perform raw data verification.
• Audit formulation blendsheets for accuracy and compliance.
• Perform audits of analytical and clinical reports prepared for regulatory submission, ensuring alignment with raw data, protocols, and standards, and verifying accuracy and compliance with Zoetis and departmental policies and procedures.
• Draft required forms (e.g., APHIS 2008, Test Sample Request, etc.) to support Reference Qualification activities.
• Review and approve routine laboratory investigations.
• Support and / or author deviation investigations, ensuring documentation meets internal and regulatory requirements, is completed within established timelines, and identifies root cause.
• Review and approve corrective / preventive actions (CAPAs), ensuring effectiveness of identified actions and completion within identified timelines.
• Review and approve change control for documents and procedures, ensuring compliance with applicable regulatory standards.
• Provide QA support for product transfers and process improvement initiatives.
• Review and approve testing validation protocols and reports.
• Perform internal audits of laboratory operations to ensure compliance with corporate and regulatory requirements.
• Perform inspection readiness activities and provide QA support during Corporate and Regulatory inspections.
• Complete assigned projects by senior departmental personnel within specified timelines.
• Establish / Maintain standard operating procedures and curriculum governing program and assure compliance with the program standards and procedures.
• Participate in key teams and task forces to address reference requalification issues and other continuous improvement projects.

Education and Experience

Required Qualifications :

B.A. / B.S. in scientific discipline or a related degree with equivalent experience. Minimum of 5 years of relevant experience. Experience in developing and maintaining raw data collection systems. General understanding of contemporary & traditional bacteriology & virology techniques, as well as validation principles. Understanding of basic statistical analyses used to evaluate analytical & clinical studies. Thorough knowledge of 9CFR and EU regulations, Good Manufacturing Practices (GMPs), Good Documentation Practices (GDP), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs).

Preferred Candidate Qualification :

M.A. / M. S in biological or molecular biological sciences with a minimum of 3 years relevant experience; or DVM with applied skills in immunological, biochemical, or molecular biological assays. Strong experience with USDA and VMD regulations with thorough knowledge of 9CFR 113.8. Prior training in Lean methods and / or certification in RFT Six-Sigma applications. Prior quality assurance experience regarding documentation and change control systems.

Technical Skills and Competencies Required

Physical Position Requirements

A considerable amount of time will be spent sitting / working at a computer and processing paperwork.

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.

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 www.Zoetis.com / careers site, or (2) via email to / from addresses using only the Zoetis domain of "@zoetis.com". 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 disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.