Regulatory Compliance Associate-Specialist - Quality Operations

zoetis; Oklahoma; On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

4 weeks vacation & 13 holidays

401(k) match with profit sharing

Tuition reimbursement and Student Loan

Health, personal, and family benefits

Job summary

Zoetis in Lincoln, NE seeks a regulatory compliance professional to oversee US and international activities, focusing on USDA, DEA, and FDA regulatory work. The role covers registration change controls, annual compliance reviews, and DEA liaison support.

Responsibilities include managing production outlines, audits, recalls, and regulatory communications, with occasional extended hours. Bachelor’s degree preferred; 3+ years in manufacturing or quality operations is expected.

Qualifications

• Bachelor's degree in a relevant field preferred.
• Minimum of 3 years’ regulatory experience in manufacturing or QA.
• Experience with USDA/FDA/EU guidelines and change controls.
• Proven ability to write and review technical regulatory documents.

Responsibilities

• Manage regulatory change controls and annual compliance reviews for US and international activities.
• Support DEA compliance activities, including quarterly audits and communications.
• Maintain GMS facility documents and participate in audits and inspections.
• Prepare Annual Product Reviews and monitor market actions and recalls.
• Ensure outlines of production meet USDA/9 CFR and related standards, and support audits.

Skills

Regulatory compliance

USDA/DEA/FDA knowledge

Documentation writing

Project management

Education

Bachelor's degree preferred

3+ years regulatory experience

Tools

MS Word

Excel

Trackwise

LIMS

Veeva Vault

SAP

Job description

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

This position will conduct US domestic and international regulatory compliance activities for Lincoln Operations with emphasis on USDA, DEA, and FDA activities. This will include registration change controls and annual compliance reviews. This position will provide support to the DEA Compliance Liaison.

Hours: 1st Shift. Occasional extended hours/weekend work.

Position Responsibilities

• Management of biological registration change control, including annual outline of production review, outline update, including regulatory change requests and submission action requests. This will include Outline submissions, regulatory communications, and revisions.
• The position will require a thorough knowledge of 21CFR for controlled substances and will provide support for activities associated with DEA compliance, including quarterly audits and compliance management.
• Support annual administrative inspection review, market actions, and recalls.
• This position will manage GMS facility documents, including blueprints and legend updates periodically for multiple GMS sites.
• Perform data collection for Annual Product Reviews: Biological and Pharmaceutical products. Including trending of market actions, rework, recalls, and regulatory notifications to the USDA.
• Maintain a thorough knowledge of APHIS/USDA/FDA/EU regulatory requirements associated with the testing and manufacture of veterinary biological and pharmaceutical products.
• Participate on key teams to address quality issues and project improvements.
• Advise management of regulatory deficiencies and recommend actions when products do not meet GMS or government requirements.
• Ensures all Outlines of Production are compliant with contemporary USDA standards, 9 CFR 114, and VSM 800.206.
• Interpretation and enforcement of 9CFR, 21CFR, EU and other regulatory guidelines
• Support regulatory agency, customer, and internal audits.
• Participation in change management activities
• Maintain department Standard Operating Procedures (SOPs)
• Other responsibilities as assigned.

Education and Experience

• Bachelor's Degree preferred.
• Minimum 3 years' relevant experience. Job level based on years of relevant experience and working regulatory knowledge.
• For the GJL 040-2 level: Minimum 3-5 years of progressive experience at the OTE Lead Level or above in Manufacturing or Quality Operations
• For the GJL 060-1 level: Greater than 3 years of experience at Associate Staff level position in Manufacturing or Quality Operations
• For the GJL 060-2 level: Greater than 3 years of experience at a Staff level position in Manufacturing or Quality Operations

Technical Skills and Competencies Required

• Demonstrated ability to write and review technical documents with high attention to detail.
• Ability to establish appropriate timelines to meet project milestones under minimal supervision.
• High integrity and self-motivation.
• Proven project management skills and organization
• Ability to develop solutions to routine problems following procedures.
• Demonstrated organizational and administrative skills, in addition to proven skills in multitasking and prioritizing projects in support of standard work.
• Strong communication (oral and written) with ability to communicate effectively with Team Members to facilitate completion requests and review from
• Demonstrated ability to identify issues.
• Thorough knowledge of USDA/FDA/EU regulatory requirements associated with the testing and manufacturing of veterinary biological and pharmaceutical products.
• Demonstrated ability to work with internal and external colleagues.
• Experience with MS Word, Excel, Outlook, Trackwise, LIMS, Veeva Vault and SAP

Physical Position Requirements

• This position requires sitting, standing, and walking with occasional extended hours/weekend work.

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