Uniphar Logistics · 8 hours ago
Quality Assurance Specialist
Uniphar Logistics is a trusted partner in healthcare sourcing and supply, ensuring the seamless flow of vital products across borders. They are seeking a detail-oriented Quality Assurance Specialist to support their Quality team within a pharmaceutical distribution environment, ensuring compliance with FDA, DEA, DSCSA, and GDP requirements while safeguarding product integrity.
Responsibilities
Support compliance with FDA, DEA, DSCSA, and state regulatory requirements
Maintain accurate and timely DSCSA T3 documentation (TI, TH, TS)
Assist with management of product quality complaints, deviations, CAPAs, and recalls
Ensure adherence to cGMP/GDP standards across distribution operations
Support controlled substance handling, access control, and recordkeeping
Oversee storage conditions, temperature monitoring, and excursion handling
Verify product identification, segregation, quarantine status, and traceability
Review and approve SOPs, work instructions, and quality documentation
Prepare quality metrics, reports, and summaries for leadership and clients
Maintain audit-ready records and documentation
Assist with training staff on GDP, DSCSA, DEA requirements, and SOP updates
Support regulatory and client audits and inspection readiness
Participate in change control review and risk assessment
Contribute to continuous improvement initiatives across quality processes
Qualification
Required
Bachelor's degree in Life Sciences, Pharmacy, Engineering, or a related field
Minimum of 2 years of Quality Assurance experience in a GxP-regulated environment
Working knowledge of FDA, DEA, cGMP/GDP, and DSCSA requirements
Experience with deviations, CAPAs, and quality documentation
Strong proficiency in Microsoft Office (Excel, Word, PowerPoint)
Preferred
Exceptional attention to detail and data integrity
Strong problem-solving and root cause analysis skills
Ability to communicate clearly and train operational staff
Experience with inventory management or electronic record systems
Collaborative mindset with a strong sense of ethics and accountability
Benefits
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Company
Uniphar Logistics
Uniphar Logistics, part of the Uniphar Group a €2.1 billion global life science and pharmaceutical distribution company, established a 100% life science state-of-the-art, ISO 13485 certified, pharma grade 3PL warehouse facility in Raleigh, North Carolina.