Regulatory Quality Assurance Analyst

Why consider this job opportunity

• Salary up to $61,800
• Comprehensive benefits package including health, dental, and vision benefits
• Opportunity for professional development and growth within the organization
• Supportive work environment that values ethical conduct and quality
• Paid time off, maternity leave, and parental leave available
• Flexibility with health savings accounts and other financial benefits

• Execute day‑to‑day Quality Assurance activities to ensure compliance with regulatory requirements and internal quality standards
• Manage and support complaint handling activities, including intake, investigation, and documentation
• Support Nonconformance Event (NCE) and CAPA processes, including documentation and follow‑up
• Collaborate with QA leadership and cross‑functional partners to investigate and resolve quality issues
• Adhere to SOPs and ensure accurate documentation within the Quality Management System (QMS)

• Associate degree or equivalent experience as a Veterinary Technician or Pharmacy Technician; bachelor's degree preferred in a related field
• Minimum of 1‑3 years of related experience in quality, supply chain management, or pharmaceuticals
• Strong technical writing skills with the ability to produce clear and compliant documentation
• Working knowledge of Drug Supply Chain Security Act (DSCSA)
• Strong organizational skills and ability to manage multiple priorities

• Certified Quality Professional (CQE, CQA, etc.) certification
• Lean Six Sigma or other Continuous Improvement certification
• Experience in a quality assurance role within the pharmaceutical industry
• Familiarity with regulatory inspections and quality assessments
• Demonstrated initiative and problem‑solving skills

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