Regulatory Compliance Associate-Specialist - Quality Operations

NEW Full Time 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.

• 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. 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.

• 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 21
  
  CFR 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 9
  
  CFR, 21
  
  CFR, 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.

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

• 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

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

Full time

Regular

Colleague

Location/Region:
Lincoln, Nebraska

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 zoeti to request an accommodation. Zoetis…