Quality Assurance Specialist in Regulatory Affairs

2 weeks ago

Dublin, Ohio, United States Covetrus Full time
Covetrus

Quality Assurance Analyst

OVERVIEW

Covetrus is a worldwide leader in animal health technology and services, committed to enabling veterinary practice partners to enhance health and financial results. We integrate products, services, and technology into a unified platform that connects our clients to the insights and solutions they require for optimal performance. Our dedication to the welfare of animals and their caregivers propels us to innovate within the veterinary medicine sector. Covetrus operates from Portland, Maine, employing over 5,500 individuals and serving more than 100,000 clients globally.

As an integral member of our North America Quality & Regulatory team focused on distribution, the Quality Assurance Analyst I - DSCSA plays a crucial role in supporting the activities necessary to uphold serialization and tracking information essential for the distribution of both human and veterinary pharmaceuticals. This role will act as a liaison for product serialization, serial number management processes, and track and trace regulations, while gaining expertise in DSCSA (Serialization, Electronic notification of shipments) laws and industry standards. The position will foster sustainable processes by collaborating closely with key operational personnel and vendor partners to meet business and customer quality objectives. Experience with The Drug Supply Chain Security Act (DSCSA) or within a regulated distribution environment is advantageous.

KEY RESPONSIBILITIES include, but are not limited to:
  • Assisting in the development, execution, and ongoing oversight of Drug Supply Chain Security Act (DSCSA) requirements as designated.
  • Implementing strategies for product-level traceability.
  • Investigating suspect and illegitimate product cases, collaborating with internal and external partners to resolve issues.
  • Acquiring a comprehensive understanding of the pharmaceutical supply chain, including the operations of wholesale distributors.
  • Building technical proficiency with various data sources and software applications that support supply chain data, including ERP systems and product serial data systems.
  • Contributing to the creation, revision, and implementation of In-Clinic Standard Operating Procedures (SOPs) to ensure compliance with applicable standards, including regulatory and accrediting body requirements.
  • Engaging with and maintaining strong relationships with external serialization service providers and internal stakeholders, including Operations, Procurement, Information Technology, Supplier Relations, and Regulatory Compliance.
  • Acting as a backup contact for FDA, State Board of Pharmacies, NABP, and other regulatory agencies regarding serialization data inquiries, effectively managing and providing necessary documentation for requests, and tracking trends within the Covetrus electronic Quality Management System (eQMS).
  • Serving as a backup for the authentication and approval of pedigree (track and trace) orders.
  • Assisting in the escalation and investigation of EPCIS file errors.
  • Identifying and addressing quality issues, driving them to resolution, and monitoring performance over time to enhance product quality and overall customer satisfaction. Communicating identified complaints per established procedures.
  • Performing additional duties as assigned and may cross-train to support other quality and regulatory functions.
QUALIFICATIONS:

EDUCATION AND EXPERIENCE
  • Associate's Degree (required); Bachelor's Degree (preferred) in a relevant field such as Chemistry, Biology, Health Administration, Animal Health, Business, Nursing, Pharmacy, Microbiology, or Supply Chain.
  • A minimum of 1-3 years of relevant experience with exposure to quality, supply chain management (distribution), and/or pharmaceuticals, or a combination of equivalent education and experience.
CERTIFICATIONS AND LICENSES
  • Certified Quality Professional (CQE, CQA, etc.) is a plus.
  • Lean Six Sigma (or other Continuous Improvement) certification is a plus.
SKILLS AND ABILITIES
  • Exceptional technical writing skills.
  • Knowledge of Drug Supply Chain Security Act requirements.
  • Demonstrated ethical conduct and serves as a role model.
  • Strong communication, collaboration, and team-building abilities; capacity to connect with all organizational levels and influence both internal and external stakeholders.
  • Proficient project management skills.
  • Creative problem solver who can tackle challenges and drive towards resolution.
  • Proficient in Microsoft Office Suite, including Excel, Word, and PowerPoint.
  • Solid understanding of distribution center operations.
  • Fundamental knowledge of supply chain and supplier quality.
  • Ability to follow directions, provide guidance, and recognize the importance of timely communication to ensure high-quality work output.
  • Demonstrated initiative, strong organizational skills, and attention to detail.
  • Ability to manage multiple tasks and meet stringent timelines set by federal and state agency reporting requirements or project deadlines.
  • Capacity to influence without authority to drive compliance and quality execution across the site.
  • Strong interpersonal skills and ability to engage with all levels of the organization.
TRAVEL REQUIREMENTS
  • Willingness to travel approximately 5% of the time.
We provide a comprehensive benefits package for eligible employees, including:

• 401k savings plan with company match

• Paid time off

• Paid holidays

• Maternity and parental leave

• Military leave

• Health, dental, and vision insurance

• Health savings and flexible spending accounts

• Life and disability insurance

• Identity theft protection

• Pet insurance

Covetrus is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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