Seamlessly unifying access, fulfillment, and support for faster, simpler digital pharmacy care.
QA Specialist
Location
United States
Posted
5 days ago
Salary
$63.4K - $74.5K / year
Seniority
Mid Level
Job Description
QA Specialist
Gifthealth
• Ensure day-to-day quality oversight across pharmacy operations with a focus on internal auditing, supplier quality, on-the-floor QA support, and product returns coordination. • Partner with Operations, Supply Chain and Warehouse/Logistics to maintain a robust QMS, drive compliance with quality assurance expectations, and enable safe, right-first-time dispensing. • Plan, execute, and report risk-based internal audits of receiving, storage, dispensing, packaging, cold chain, controlled substance handling, shipping, and returns. • Track observations, grade findings, and drive CAPA effectiveness through to verified closure. • Perform supplier qualification and re-qualification (manufacturers, wholesalers, 3PLs, reverse distributors, packaging, couriers). • Provide line/area QA oversight in real time (lot/expiry verification, label checks, line clearance, pack verification, temperature excursion assessments). • Own the returns and reverse logistics quality process: intake, segregation/quarantine, evaluation, disposition, and documentation.
Job Requirements
- 2–5 years in Quality Assurance within pharmacy operations, pharmaceutical distribution, 503A/central fill, 503B, or related GxP environment.
- Working knowledge of state Board of Pharmacy, DEA, and applicable FDA/GMP requirements.
- Hands-on experience with internal audits, CAPA, deviation/complaint investigations, and supplier qualification.
- Experience with a QMS/eQMS (e.g., TrackWise or similar) including change control, document control, training, and CAPA workflows.
- Zendesk or comparable ticketing/case-management platform experience for issue intake, triage, and customer-impact documentation.
- Strong attention to detail; clear written/verbal communication; ability to influence cross-functionally under time pressure.
Benefits
- Equal Employment Opportunity (EEO)
- Professional development opportunities
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