About the CompanyQuality Assurance (QA) Specialist – Sterile Compounding (USP) Reports To QA Manager and/or Pharmacist-in-Charge (PIC)About the RoleThe Quality Assurance (QA) Specialist – Sterile Compounding supports the Quality Management System (QMS) for a 503A pharmacy limited to sterile operations under USP. This role focuses on document control, environmental monitoring support, aseptic process compliance, deviation tracking, and inspection readiness to ensure ongoing compliance with USP, FDA expectations, and applicable state board of pharmacy requirements.ResponsibilitiesMaintain and control SOPs, logs, and records related to sterile compoundingEnsure USP procedures are current and accurately implementedPerform routine cleanroom and buffer area compliance walkthroughsSupport internal audits and inspection readiness activitiesAssist during FDA and state board inspectionsDocument and track deviations, incidents, and nonconformancesSupport root cause analysis and CAPA implementationTrack and trend quality findings for sterile operationsSupport media fill documentation and aseptic process validationsMaintain personnel qualification and requalification records QualificationsAssociate’s or Bachelor’s degree in Life Sciences, Quality, Pharmacy, or related field (or equivalent experience)1–3 years experience in sterile compounding, quality, or regulated healthcare environmentWorking knowledge of USPStrong documentation and organizational skills Required SkillsAttention to detail and compliance accuracyStrong written and verbal communicationAbility to recognize and escalate sterility risksTime management and prioritization skillsProficiency with Excel and quality tracking tools Preferred SkillsExperience in a 503A sterile compounding pharmacyCleanroom or ISO-classified environment experienceFamiliarity with FDA or state board inspectionsPharmacy Technician Certification (CPhT)