QA Specialist — Pharmacy Operations

Gifthealth • Columbus, OH

2d • Onsite

About The Position

The QA Specialist ensures 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. You’ll 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.

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.

Nice To Haves

• CPhT or state Pharmacy Technician license; RAC, ASQ CQA, or similar quality certification.
• Experience with temperature-controlled logistics, courier oversight, and excursion management.
• Familiarity with serialization/traceability, lot control, and recall execution.
• Prior work in a mail-order/central fill or high-throughput pharmacy environment.

Responsibilities

• Internal Audit (˜35%) 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. Trend audit data, prepare dashboards/metrics, and present results in quality reviews and readiness checks.
• Supplier Quality (˜25%) Perform supplier qualification and re-qualification (manufacturers, wholesalers, 3PLs, reverse distributors, packaging, couriers). Maintain the Approved Supplier List, quality agreements, and risk profiles. Manage supplier complaints, investigations, and corrective actions; monitor supplier performance (OTIF, defects, excursions, recalls).
• QA on the Floor (˜25%) Provide line/area QA oversight in real time (lot/expiry verification, label checks, line clearance, pack verification, temperature excursion assessments). Review/approve operational records and release/quarantine decisions per SOPs. Coach teams on GMP/GDP behaviors; support training, change control, and document control. Participate in deviation/incident investigations; perform root cause analysis and implement systemic fixes.
• Product Returns & Recalls (˜15%) Own the returns and reverse logistics quality process: intake, segregation/quarantine, evaluation, disposition, and documentation. Coordinate with reverse distributors and suppliers; ensure compliant handling of controlled substances. Support/coordinate recalls and field actions: traceability, lot verification, notifications, execution, and effectiveness checks.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 51-100 employees