Quality Assurance; QA Specialist – Sterile Compounding

Quality Assurance (QA) Specialist – Sterile Compounding (USP) Reports To QA Manager and/or Pharmacist-in-Charge (PIC) About the Role

The 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.

• Maintain and control SOPs, logs, and records related to sterile compounding
• Ensure USP procedures are current and accurately implemented
• Perform routine cleanroom and buffer area compliance walkthroughs
• Support internal audits and inspection readiness activities
• Assist during FDA and state board inspections
• Document and track deviations, incidents, and nonconformances
• Support root cause analysis and CAPA implementation
• Track and trend quality findings for sterile operations
• Support media fill documentation and aseptic process validations
• Maintain personnel qualification and requalification records

• Associate’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 environment
• Working knowledge of USP
• Strong documentation and organizational skills

• Attention to detail and compliance accuracy
• Strong written and verbal communication
• Ability to recognize and escalate sterility risks
• Time management and prioritization skills
• Proficiency with Excel and quality tracking tools

• Experience in a 503A sterile compounding pharmacy
• Cleanroom or ISO-classified environment experience
• Familiarity with FDA or state board inspections