Regulatory Compliance Associate-Specialist - Quality Operations
Zoetis
August 19, 2026
On-site
Lincoln, NE
Operations
Position Summary
This position will conduct US domestic and international regulatory compliance activities for Lincoln Operations with emphasis on USDA, DEA, and FDA activities, including registration change controls and annual compliance reviews. Provides support to the DEA Compliance Liaison.
Hours: 1st Shift. Occasional extended hours/weekend work.
Position Responsibilities
- Manage biological registration change control (annual outline of production review, outline updates, regulatory change requests, submission action requests, outline submissions, regulatory communications, and revisions).
- Use thorough knowledge of 21 CFR for controlled substances; support DEA compliance activities, including quarterly audits and compliance management.
- Support annual administrative inspection review, market actions, and recalls.
- Manage GMS facility documents (blueprints and legend updates) for multiple GMS sites.
- Perform data collection for Annual Product Reviews (biological and pharmaceutical), including trending of market actions, rework, recalls, and regulatory notifications to USDA.
- Maintain knowledge of APHIS/USDA/FDA/EU regulatory requirements for veterinary biological and pharmaceutical testing/manufacture.
- Participate on teams to address quality issues and project improvements.
- Advise management on regulatory deficiencies and recommend actions.
- Ensure Outlines of Production comply with USDA standards (9 CFR 114, VSM 800.206).
- Interpret and enforce 9 CFR, 21 CFR, EU, and other regulatory guidelines.
- Support regulatory agency, customer, and internal audits; participate in change management; maintain department SOPs; other assigned responsibilities.
Education and Experience
- Bachelor’s degree preferred.
- Minimum 3 years relevant experience (job level varies by years/role).
Technical Skills and Competencies Required
- Ability to write/review technical documents with high attention to detail.
- Establish timelines to meet milestones under minimal supervision.
- High integrity and self-motivation; proven project management/organization.
- Develop solutions to routine problems using procedures.
- Strong organizational/administrative skills; multitasking/prioritizing.
- Strong oral and written communication.
- Demonstrated ability to identify issues.
- Thorough knowledge of USDA/FDA/EU veterinary biological/pharmaceutical manufacturing/testing requirements.
- Work effectively with internal/external colleagues.
- Proficiency with MS Word, Excel, Outlook, Trackwise, LIMS, Veeva Vault, and SAP.
Physical Position Requirements
- Sitting, standing, and walking with occasional extended hours/weekend work.
Benefits
- 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.
This position will conduct US domestic and international regulatory compliance activities for Lincoln Operations with emphasis on USDA, DEA, and FDA activities, including registration change controls and annual compliance reviews. Provides support to the DEA Compliance Liaison.
Hours: 1st Shift. Occasional extended hours/weekend work.
Position Responsibilities
- Manage biological registration change control (annual outline of production review, outline updates, regulatory change requests, submission action requests, outline submissions, regulatory communications, and revisions).
- Use thorough knowledge of 21 CFR for controlled substances; support DEA compliance activities, including quarterly audits and compliance management.
- Support annual administrative inspection review, market actions, and recalls.
- Manage GMS facility documents (blueprints and legend updates) for multiple GMS sites.
- Perform data collection for Annual Product Reviews (biological and pharmaceutical), including trending of market actions, rework, recalls, and regulatory notifications to USDA.
- Maintain knowledge of APHIS/USDA/FDA/EU regulatory requirements for veterinary biological and pharmaceutical testing/manufacture.
- Participate on teams to address quality issues and project improvements.
- Advise management on regulatory deficiencies and recommend actions.
- Ensure Outlines of Production comply with USDA standards (9 CFR 114, VSM 800.206).
- Interpret and enforce 9 CFR, 21 CFR, EU, and other regulatory guidelines.
- Support regulatory agency, customer, and internal audits; participate in change management; maintain department SOPs; other assigned responsibilities.
Education and Experience
- Bachelor’s degree preferred.
- Minimum 3 years relevant experience (job level varies by years/role).
Technical Skills and Competencies Required
- Ability to write/review technical documents with high attention to detail.
- Establish timelines to meet milestones under minimal supervision.
- High integrity and self-motivation; proven project management/organization.
- Develop solutions to routine problems using procedures.
- Strong organizational/administrative skills; multitasking/prioritizing.
- Strong oral and written communication.
- Demonstrated ability to identify issues.
- Thorough knowledge of USDA/FDA/EU veterinary biological/pharmaceutical manufacturing/testing requirements.
- Work effectively with internal/external colleagues.
- Proficiency with MS Word, Excel, Outlook, Trackwise, LIMS, Veeva Vault, and SAP.
Physical Position Requirements
- Sitting, standing, and walking with occasional extended hours/weekend work.
Benefits
- 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.