Compliance 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

Perform activities necessary to maintain regulatory documentation, and process controls to ensure program compliance with FDA, USDA, International Market, GMP regulations, Global Quality Standards, and other applicable regulations, as well as site policies and procedures.

Hours: 1st shift hours, Monday - Friday.

Position Responsibilities

• Lead and manage change control processes for QC labs, including regulatory document updates (e.g., LIMS, MCD revisions, impact assessments).
• Review and audit study protocols, reports, and data files to ensure regulatory compliance and data integrity.
• Drive closure of internal and regulatory audit compliance actions and support annual compliance assessments.
• Coordinate the Outline Review process and assist with reagent shipments to regulatory agencies.
• Participate in QC compliance investigations and support the BCL Surveillance Program.
• Organize and lead monthly team leader meetings, lab walkthroughs, and working sessions to enhance collaboration and compliance.
• Streamline SOPs and lab processes, ensuring timely completion of ETS and VV commitments.
• Track and analyze lab metrics for process improvement and provide compliance support across all lab teams.
• Complete projects assigned by senior departmental personnel within specified timelines.

Education and Experience

Required Qualifications:

B.A./B.S. in science or related degree with equivalent experience. Minimum of 5 years relevant experience. General understanding of contemporary & traditional bacteriology & virology techniques, and validation principles. Thorough knowledge of 9CFR and EU regulations, Good Manufacturing Practices (GMPs), 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; skills in immuno-, biochemical, or molecular biological assays. Experience in USDA and VMD regulations with knowledge of 9CFR 113.8. Prior quality assurance experience regarding documentation and change control systems.

Technical Skills and Competencies Required

Demonstrated ability to write and review technical documents with demonstrated high level of attention to detail. High integrity and self-motivation. Strong communication (oral and written), interpersonal, and team/group interactive skills.

Physical Position Requirements

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

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.