Regulatory Quality Assurance Specialist

4 weeks ago


Dublin, Texas, United States Covetrus North America, LLC Full time

Covetrus North America, LLC Job Description

Job Title: Regulatory Quality Assurance Analyst

Job Summary:

We are seeking a highly skilled Regulatory Quality Assurance Analyst to join our North America Quality & Regulatory team. As a key member of our team, you will be responsible for supporting activities required to maintain serialization and track and trace information for the distribution of human and veterinary pharmaceuticals.

Key Responsibilities:

  • Support the development, implementation, and ongoing management of Drug Supply Chain Security Act (DSCSA) requirements
  • Execute plans for product level traceability
  • Review and manage suspect and illegitimate product investigations
  • Develop a thorough understanding of the pharmaceutical supply chain
  • Support the generation, revision, and implementation of In-Clinic Standard Operating Procedures (SOPs)
  • Interact with and maintain strong partnerships with external suppliers of serialization services
  • Serve as a backup point of contact for FDA, State Board of Pharmacies, NABP, and other regulatory agencies

Requirements:

  • Associate's Degree (required) in a related field: Chemistry, Biology, Health Administration, Animal Health, Business, Nursing, Pharmacy, Microbiology, Supply Chain
  • Minimum of 1-3 years of related experience with exposure to quality, supply chain management (distribution), and/or pharmaceuticals

About Covetrus North America, LLC:

Covetrus is a global animal-health technology and services company dedicated to empowering veterinary practice partners to drive improved health and financial outcomes. We are bringing together products, services, and technology into a single platform that connects our customers to the solutions and insights they need to work best.



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