Description
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.
Key ResponsibilitiesInternal 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.
- 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.
- 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.
- Location: On-site
- Schedule: Full-time
- May require additional availability or flexibility for audits or investigations.
- Regular meetings with teams, departments, or leadership to ensure alignment.
- Must be able to stand for at least 8 hours at a time while working
- Ability to lift up to ~25 lbs. occasionally; extended periods standing on the floor.
Status: Full-time
FLSA: Non-Exempt
Gifthealth is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, national origin, age, disability, veteran status, or any other legally protected status.
We celebrate diversity and are committed to creating an inclusive environment for all employees. If you do not meet every requirement but still feel you would be a great fit for this role, we encourage you to apply!
DisclaimerThis job description is intended to describe the general nature and level of work being performed. It is not intended to be an exhaustive list of all responsibilities, duties, or skills required of personnel. Gifthealth reserves the right to modify job duties or descriptions at any time.
Skills Required
- 5+ years in Quality Assurance within pharmacy operations, pharmaceutical distribution, 503A/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) including change control, document control, training, and CAPA workflows.
- Zendesk or comparable ticketing/case-management platform experience for issue intake and triage.
- Strong attention to detail; clear written/verbal communication; ability to influence cross-functionally under time pressure.
- Ability to stand for at least 8 hours and occasionally lift up to ~25 lbs.
- 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.
What We Do
Gifthealth is a digital pharmacy and access platform that streamlines prescription fulfillment, reduces patient out-of-pocket costs, and improves persistence for biopharma brands and their clinics. As the first digital pharmacy to offer direct-to-patient services at scale, it connects prescribers, patients, and partners through a seamless, end-to-end experience to remove barriers across the entire prescription journey.
