Regulatory QA Analyst

Regulatory QA Analyst at Covetrus

The Quality Assurance Analyst role executes Quality Assurance related tasks for In-Clinic & Pharmacy Quality Assurance (QA). This role works closely with and under the leadership of the Quality Assurance Supervisor to ensure that procedural and operational practices are executed consistently and effectively, meeting all regulatory requirements while supporting business needs through proactive, efficient, standardized quality processes.

Responsibilities

Quality Operations & Execution

• Execute day-to-day Quality Assurance activities to ensure products, suppliers, and processes comply with regulatory requirements and internal quality standards.
• Manage and support complaint handling activities, including intake, investigation, documentation, corrective actions, and closure.
• Support Nonconformance Event (NCE) and CAPA processes, including initiation, investigation support, follow-up, and documentation.
• Consistently execute quality activities related to:
  • Recall support and documentation
  • Supplier approval and ongoing monitoring
  • Drug Supply Chain Security Act (DSCSA) compliance
  • In-Clinic new item add approvals

Compliance & Documentation

• Adhere to SOPs, work instructions, regulatory requirements, and quality standards.
• Ensure accurate, timely, and compliant documentation within the Quality Management System (QMS).
• Identify, document, and escalate quality risks, deviations, and trends as appropriate.

Collaboration & Continuous Improvement

• Support internal audits, regulatory inspections, and quality assessments.
• Identify process inefficiencies, quality issues, and potential risks; communicate findings to the Quality Assurance Supervisor and support improvement initiatives.
• Collaborate with QA leadership and cross-functional partners to investigate and resolve quality issues.
• Complete all required training in accordance with established timelines.
• Perform other duties as assigned to support quality and business objectives.

Required Knowledge and Skills

• Strong technical writing skills with the ability to produce clear, accurate, and compliant documentation.
• Working knowledge of Drug Supply Chain Security Act (DSCSA).
• Demonstrated ethical conduct; serves as a role model for quality and compliance.
• Strong verbal and written communication skills, with the ability to collaborate effectively across all levels of the organization.
• Strong organizational skills, attention to detail, and the ability to manage multiple priorities and meet tight timelines.
• Demonstrated initiative and problem-solving skills with the ability to drive issues to resolution.
• Proficiency in Microsoft Office applications (Excel, Word, PowerPoint).
• Ability to take direction, provide input, and recognize when to escalate or seek collaboration to ensure high-quality outcomes.

Education

• Associate degree or equivalent experience, such as certification and professional practice as a Veterinary Technician or Pharmacy Technician (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

Key skills/competency

• Quality Assurance
• Regulatory Compliance
• Complaint Handling
• CAPA
• DSCSA
• SOPs
• Technical Writing
• Quality Management System (QMS)
• Process Improvement
• Audit Support