Regulatory Compliance Associate-Specialist - Quality Operations

Zoetis is the world's largest manufacturer and supplier of animal pharmaceuticals. At the Lincoln, NE site, we produce high-quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of Nebraska's Safest Companies and maintains a long-standing presence in the Lincoln community. We are a clean, modern facility that continues to innovate and grow.

About the role

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

Hours: 1st Shift. Occasional extended hours and weekend work may be required.

Responsibilities

• Management of biological registration change control, including annual outline of production review, outline updates, regulatory change requests, and submission action requests. This includes outline submissions, regulatory communications, and revisions.
• Provide support for DEA compliance activities, including quarterly audits and compliance management, requiring thorough knowledge of 21 CFR for controlled substances.
• Support annual administrative inspection reviews, market actions, and recalls.
• Manage GMS facility documents, including blueprints and legend updates periodically for multiple GMS sites.
• Perform data collection for Annual Product Reviews for biological and pharmaceutical products, including trending of market actions, rework, recalls, and regulatory notifications to the USDA.
• Maintain 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.
• Ensure all Outlines of Production are compliant with contemporary USDA standards, 9 CFR 114, and 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 activities.
• Maintain department Standard Operating Procedures (SOPs).
• Other responsibilities as assigned.

Requirements

• 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.

Skills

• 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 reviews.
• 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 and 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.
• Comprehensive health, personal, and family benefits starting on day 1.

About Zoetis

At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture, and commercialize vaccines, medicines, diagnostics, and other technologies for companion animals and livestock. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection, and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies, and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.