QA Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide daily quality oversight for pharmacy operations, emphasizing internal auditing, supplier quality, on-the-floor QA support, and coordination of product returns.

• Collaborate with Operations, Supply Chain, and Warehouse/Logistics to uphold a comprehensive Quality Management System (QMS), ensure compliance with quality assurance standards, and facilitate safe, accurate dispensing.

• Plan, implement, and report on risk-based internal audits covering receiving, storage, dispensing, packaging, cold chain, controlled substance handling, shipping, and returns.

• Monitor observations, assess findings, and enhance Corrective and Preventive Action (CAPA) effectiveness until verified closure.

• Conduct supplier qualification and re-qualification processes for manufacturers, wholesalers, third-party logistics (3PLs), reverse distributors, packaging entities, and couriers.

• Deliver real-time QA oversight in designated areas (including lot/expiry verification, label checks, line clearance, pack verification, and temperature excursion assessments).

• Manage the returns and reverse logistics quality process, encompassing intake, segregation/quarantine, evaluation, disposition, and documentation.

⛳️ Requirements

• 2–5 years of experience in Quality Assurance within pharmacy operations, pharmaceutical distribution, 503A/central fill, 503B, or a related Good Practice (GxP) environment.

• Proficient understanding of state Board of Pharmacy regulations, DEA guidelines, and relevant FDA/GMP standards.

• Practical experience with internal audits, CAPA processes, deviation/complaint investigations, and supplier qualification.

• Familiarity with a Quality Management System/electronic Quality Management System (eQMS) such as TrackWise or similar, which includes change control, document control, training, and CAPA workflows.

• Experience with Zendesk or a similar ticketing/case-management platform for issue intake, triage, and documentation of customer impact.

• Exceptional attention to detail; strong written and verbal communication skills; ability to influence across functions under time constraints.

🏝️ Benefits

• Equal Employment Opportunity (EEO)

• Professional development opportunities