Quality Technician – Sterile Compounding

Quality Assurance (QA) Specialist or QA Manager About the Role

The Quality Technician – Sterile Compounding supports daily quality and compliance activities for a 503A pharmacy limited to sterile operations under USP. This entry‑level quality role focuses on documentation review, routine compliance checks, environmental monitoring support, and data tracking to ensure ongoing sterility assurance, regulatory compliance, and inspection readiness.

• Maintain quality records, logs, and forms related to sterile compounding
• Perform routine reviews of compounding, cleaning, and monitoring logs
• Identify documentation errors and elevate discrepancies
• Support daily and scheduled cleanroom compliance walkthroughs
• Verify adherence to USP procedures and work instructions
• Escalate observed deviations or potential sterility risks
• Assist with documentation of deviations, incidents, and near‑misses
• Collect and organize supporting records for investigations
• Track assigned corrective actions under QA supervision
• Assist with collection of viable and non‑viable environmental monitoring samples
• Label, document, and track EM samples and results
• Notify QA leadership of out‑of‑specification or action‑level results
• Maintain EM logs and assist with trending activities

• Track USP training and competency records
• Verify completion of gowning and aseptic technique qualifications
• Support onboarding documentation for sterile compounding personnel
• Assist with media fill and personnel qualification documentation

• Assist with receipt and documentation of sterile supplies and components
• Verify lot numbers, expiration dates, and supporting documentation
• Support quarantine and release processes under QA direction

• Support internal audits and mock inspections
• Organize quality records for FDA and state board inspections

• High school diploma or equivalent (Associate’s degree preferred)
• 1–2 years experience in sterile compounding, healthcare, or regulated environment
• Ability to follow written procedures and maintain accurate documentation
• Computer and data entry skills

• Experience in a 503A sterile compounding pharmacy
• Cleanroom or ISO‑classified environment experience
• Exposure to USP
• High attention to detail and sterility awareness
• Strong documentation and organizational skills
• Ability to recognize and escape sterility risks
• Clear written and verbal communication
• Ability to work in controlled environments

• Sterile compounding and cleanroom environments
• Required gowning and controlled area access
• Standing, walking, and light lifting in controlled areas

• Accuracy of documentation reviews
• Training and qualification tracking accuracy
• Inspection readiness support effectiveness