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Regulatory Support Coordinator

Zoetis

Last Updated: 10/19/21

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 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.

Full time

Regular

Colleague

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 [Register to View] to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of [Register to View] In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.



Company Details

Parsippany, New Jersey, United States
Zoetis discovers, develops, manufactures and commercializes medicines, vaccines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.