QA Specialist

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Gifthealth

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2020

☁️ SaaS

💊 Pharmaceuticals

🤝 B2B

💰 $40M Private Equity Round - GiftHealth on 2023-04

SaaS • Pharmaceuticals • B2B

Gifthealth is a technology-enabled patient access and prescription fulfillment company that connects patients, prescribers, pharmacies, and pharmaceutical manufacturers through a unified digital platform. It streamlines enrollment, electronic benefits verification, e-prior authorization, and payment/affordability support while managing pharmacy fulfillment and patient support services. The platform also provides manufacturers with actionable data and insights on patient journeys and brand performance, driving faster, more reliable medication access.

📋 Description

• 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.

🎯 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