Pharmacy Compliance Analyst

About the CompanyThe Pharmacy Compliance Quality Systems Analyst supports the Senior Director of Compliance in maintaining regulatory compliance, inspection readiness, and Quality Management System (QMS) integrity across multiple 503A compounding pharmacies operating in Texas, California, and Alabama.About the RoleThis role functions as the operational backbone of the compliance program and is responsible for CAPA management, audit coordination, documentation control, licensing support, training oversight, and cross-site regulatory standardization under USP, USP, USP, USP, state Board of Pharmacy regulations, and FDA guidance for 503A pharmacies.ResponsibilitiesFacilitate CAPA initiation, root cause analysis (RCA), and effectiveness checksOwn and maintain the Master CAPA Tracker across all sitesTrack closure timelines and escalate overdue actionsMaintain inspection-ready documentation binders (electronic + site-specific)Coordinate mock inspections (Texas BOP, CA BOP, AL BOP, FDA)Track remediation items from board inspectionsMaintain board correspondence filesSupport DEA, state, and non-resident PIC license trackingMaintain Pharmacy Network License Workup trackerTrack pharmacist, technician, and trainee licensesMonitor supervision ratiosTrack non-resident pharmacy licensing requirementsMonitor renewal deadlines and documentation completenessMaintain sterile compounding competency trackerAssist with training documentation standardization across all sitesMonitor new hire onboarding complianceMaintain master SOP indexEnsure SOP alignment across multiple statesEnsure document version control integrityThis position may assume additional responsibilities as required to meet organizational objectives and support operational priorities.QualificationsRequired:Bachelor's degree in science, pharmacy, regulatory affairs, or healthcare administration5+ years experience in pharmacy compliance, sterile compounding, or healthcare quality systemsWorking knowledge of USP, USPStrong Excel and data analysis skillsExperience with CAPA and QMS systemsStrong analytical and documentation skillsPreferred:503A and/or 503B sterile compounding experienceMulti-state regulatory exposureExperience preparing for board or FDA inspectionsCertification in Quality or Regulatory Affairs (CQA, RAC, etc.)

Created: 2026-05-08