(Archived) Regulatory Support Coordinator

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 Lincoln and we continue to grow.

Benefits Include:

Great Health Benefits from day 1!

3 weeks accrued paid vacation and 13 paid holidays

401(k) match with company profit sharing

Tuition reimbursement

Position Summary

This position will assist/perform regulatory support activities associated with Annual Product Review, Product Complaint Investigations and Product Stability to ensure compliance with USDA, EU, FDA, and company standards.

Position Responsibilities

• Assist/perform pharmaceutical and biological regulatory support activities that may include:
  • Assist/prepare stability protocols and identify stability serials/lots
  • Preparation, scheduling, and labeling of stability samples for storage, testing and disposal.
  • Data collection for Periodic Product Reviews (PPR) and Product Stability; may include data retrieval and formatting, preparation of binders, data queries in to change management, documentation, investigation, adequacy of corrective actions, and LIMS system(s).
  • Perform trend analysis using Minitab, or equivalent software
  • Prepare reports and/or summaries for internal and external use
• Assist with Stability Sample pulling, logging, and distribution, pharmaceutical focus
• Assist/prepare annual PPR schedule for pharmaceutical products.
• Assist with LIMS activities including inspection plan maintenance, initiating stability studies, scheduling, sampling, label generation and result entry/verification, as needed.
• Maintain stability chambers
• Assist/Perform complaint investigations for Biological and/or Pharmaceutical products
• Perform other duties and special projects, as assigned

Education and Experience

Educational Background:

Minimum

• High School Diploma or equivalent
• 1-3 years (GJL 020-1), 4-8 years (GJL 020-2), or 8+ years (GJL 030-1) relevant work experience preferred

Work Experience/Skills:

Minimum

• Demonstration of organizational and interpersonal skills as well as written and oral communication skills.

• Demonstrated ability to review technical documents with high attention to detail
• High integrity and self-motivation
• Experience/participation in Manufacturing and Laboratory investigations
• Experience with computer-based Quality systems

Preferred Qualifications

Knowledge of 9 CFR, Outline of Production, Bill of Specifications, Monographs, QAALS, and Registration Specifications. Knowledge of Veeva Vault and Laboratory Information Systems. Exposure to pharmaceutical and/or biological vaccine manufacturing processes with understanding of basic analytical & biological testing procedures and practices.

Technical Skills and Competencies Required

Demonstrated ability to write and review technical documents with high level of attention to detail. Candidate must have high integrity, self-motivation, strong communication (oral and written), interpersonal, and team/group interactive skills. Proficiency in Microsoft Office applications.

Physical Position Requirements

Computer based position.