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Regulatory Quality Assurance Specialist

2 months ago

Dublin, Ohio, United States Covetrus North America, LLC Full time
About the Role

Covetrus North America, LLC is a leading 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.

Job Summary

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

Key Responsibilities
  • Support the development, implementation, and ongoing management of Drug Supply Chain Security Act (DSCSA) requirements, as assigned
  • Execute plans for product level traceability
  • Review and manage suspect and illegitimate product investigations and work with internal and external partners to resolve issues
  • Develop a thorough understanding of the pharmaceutical supply chain, including products and operations of wholesale distributors
  • Develop technical competency working with various data sources and software programs supporting supply chain data, including ERP systems and product serial data systems
  • Support the generation, revision, and implementation of In-Clinic Standard Operating Procedures (SOPs) ensuring the distribution (In-Clinic) business operates in accordance with applicable standards, including any regulatory and accrediting body requirements
  • Interact with and maintain strong partnerships with external suppliers of serialization services as well as internal stakeholders, including Operations, Procurement, Information Technology, Supplier Relations, and Regulatory Compliance
  • Serve as a backup point of contact for FDA, State Board of Pharmacies, NABP, and/or other regulatory agencies on serialization data requests
  • Effectively manage and provide applicable documentation for requests and track/trend requests within the Covetrus electronic Quality Management System (eQMS) software application
  • Serve as backup for authenticating and approving pedigree (track and trace) orders
  • Serve as backup for EPCIS file errors escalation and investigation
  • Identify and raise quality issues and drive them to resolution
  • Monitor performance over time with a focus on improving product quality and overall customer experience
  • Communicate identified complaints per established process
Requirements
  • Associate's Degree (required)
  • Bachelor's Degree (preferred) 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 or combination thereof