QA Specialist

Gifthealth

QA Specialist ensuring quality oversight across pharmacy operations at Gifthealth. Collaborating with Operations and Supply Chain for compliance with quality assurance expectations.

Posted 6/30/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-Level💰 $63,357 - $74,538 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance within pharmacy operations, focusing on internal auditing, supplier qualification, and compliance with FDA/GMP requirements. Proficient in managing quality processes, including CAPA effectiveness and QMS oversight.

Highest-signal resume keywords

Quality Assurance ExperienceInternal AuditsSupplier QualificationQMS/eQMS ProficiencyAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Internal AuditingCAPA ManagementDeviation InvestigationsSupplier QualificationQuality Management System (QMS)Change ControlDocument ControlRisk-Based AuditsControlled Substance HandlingTemperature Excursion Assessments

Soft Skills

Clear CommunicationCross-Functional InfluenceAttention to Detail

Tools & Technologies

TrackWiseZendeskCase Management Platforms

Industry Keywords

Pharmacy OperationsPharmaceutical DistributionGxP EnvironmentFDA RequirementsGMP ComplianceBoard of PharmacyDEA Regulations

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Equal Employment Opportunity (EEO)
Professional development opportunities