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Quality Technician 503A Sterile Compounding
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Link Pharmacy
Highland Village, TX (In Person)
$56,160 Salary, Full-Time
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Job Description
Quality Technician - 503A Sterile Compounding Reports To Quality Assurance (QA) Specialist or QA Manager Position Summary The Quality Technician - Sterile Compounding supports daily quality and compliance activities for a 503A pharmacy limited to sterile operations under USP <797>. 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. Essential Duties and Responsibilities Maintain quality records, logs, and forms related to sterile compounding Perform routine reviews of compounding, cleaning, and monitoring logs Identify documentation errors and escalate discrepancies Support daily and scheduled cleanroom compliance walkthroughs Verify adherence to USP <797> 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 Environmental Monitoring Support 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 Training & Qualification Support Track USP <797> 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 Materials & Sterile Supply Quality 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 Audit & Inspection Readiness Support internal audits and mock inspections Organize quality records for FDA and state board inspections Provide documentation support during inspections Qualifications - Required 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 Basic computer and data entry skills Qualifications - Preferred Experience in a 503A sterile compounding pharmacy Cleanroom or ISO-classified environment experience Exposure to USP <797> Pharmacy Technician Certification (CPhT) Skills & Competencies High attention to detail and sterility awareness Strong documentation and organizational skills Ability to recognize and escalate sterility risks Clear written and verbal communication Ability to work in controlled environments Working Conditions Sterile compounding and cleanroom environments Required gowning and controlled area access Standing, walking, and light lifting in controlled areas Key Performance Indicators (KPIs) Accuracy of documentation reviews Environmental monitoring support compliance Training and qualification tracking accuracy Inspection readiness support effectiveness