Quality Assurance Analyst I

4 weeks ago

Dublin, United States Covetrus North America, LLC Full time

SUMMARY Covetrus is an innovative technology leader that helps veterinarians grow their practices and engage with their pet owners every day. As a key member of our North America Quality & Regulatory team supporting distribution, theQuality Assurance Analyst I - DSCSA is responsible for supporting activities required to maintain serialization and track and trace information required for distribution of human and veterinary pharmaceuticals. This position will serve as a point of contact for product serialization, serial number management processes, track and trace regulations, and become knowledgeable regarding DSCSA (Serialization, Electronic notification of shipments) laws and Industry standards. This position will support sustainable processes, by working closely with key operations personnel and vendor partners to achieve business & customer quality goals. Experience in The Drug Supply Chain Security Act (DSCSA) or a regulated distribution business is preferred. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Supports the development, implementation, and ongoing management of Drug Supply Chain Security Act (DSCSA) requirements, as assigned Executes plans for product level traceability. Reviews and manages suspect and illegitimate product investigations and works with internal and external partners to resolve issues. Develops a thorough understanding of the pharmaceutical supply chain including products and operations of wholesale distributors. Develops technical competency working with various data sources and software programs supporting supply chain data, including ERP systems and product serial data systems. Supports the generation, revision & implementation of In-Clinic Standard Operating Procedures (SOPs) ensuring the distribution (In-Clinic) business operates in accordance with applicable standards including any regulatory & accrediting body requirements. As assigned, interacts with and maintains strong partnerships with external suppliers of serialization services as well as internal stakeholders including Operations, Procurement, Information Technology, Supplier Relations and Regulatory Compliance. Serves as a backup point of contact for FDA, State Board of Pharmacies, NABP and/or other regulatory agencies on serialization data requests. Effectively manages and provides applicable documentation for requests and track/trend requests within the Covetrus electronic Quality Management System (eQMS) software application. Serves as backup for authenticating and approving pedigree (track and trace) orders Serves as backup for EPCIS file errors escalation and investigation Identifies and raises quality issues and drives them to resolution. Monitors performance over time with a focus on improving product quality & overall customer experience. Communicates identified complaints per established process. Performs additional duties as assigned and may cross-train to support other quality and regulatory activities. QUALIFICATIONS: EDUCATION AND/OR EXPERIENCE 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 of equivalent education and experience. CERTIFICATES, LICENSES, REGISTRATIONS Certified Quality Professional (CQE, CQA, etc.) a plus Lean Six Sigma (or other Continuous Improvement) certification a plus COMPETENCIES (SKILLS AND ABILITIES) Strong technical writing skills Knowledge of the Drug Supply Chain Security Act requirements Ethical conduct. Serves as a role model Strong communication, collaboration, and team-building skills; ability to connect with al

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