Sterile Compounding Technician

As a Sterile Compounding Pharmacy Technician, you will prepare compounded sterile preparations (CSPs) under the direct supervision of a licensed pharmacist, in strict accordance with USP <797>, USP <800>, state Board of Pharmacy regulations, and facility standard operating procedures. You will be responsible for maintaining aseptic technique, accurate documentation, and cleanroom integrity across all stages of compounding.

Prepare CSPs from master formulation records, including admixtures, syringes, vials, and batch preparationsPerform all manipulations within an ISO Class 5 primary engineering control (LAFW, BSC, or CAI/CACI) using validated aseptic techniqueAccurately calculate, measure, and reconcile ingredient quantities; verify NDCs, lot numbers, and expiration datesStage and label preparations for pharmacist verification; never release a CSP without a documented final checkAssign beyond-use dates per approved formulation records and applicable USP standardsSupport batch production runs, including in-process checks and yield reconciliation

Complete garbing, hand hygiene, and gowning per SOP prior to entering classified areasMaintain and document ongoing competency, including gloved fingertip/thumb sampling and media-fill validation at required intervalsPerform and log routine cleaning and disinfection of PECs, SECs, and ancillary surfacesSupport environmental monitoring: viable and nonviable air sampling, surface sampling, pressure differential and temperature/humidity loggingHandle hazardous drugs per USP <800>, including appropriate PPE, closed-system transfer devices, and spill responseReport deviations, near misses, and out-of-specification results promptly

Complete compounding records, cleaning logs, and monitoring documentation legibly, contemporaneously, and completelyMaintain inventory of APIs, excipients, containers, closures, and consumables; rotate stock and monitor for expiryAssist with recall response, quarantine of suspect materials, and destruction documentationSupport internal audits and regulatory inspections as directed

PTCB Certified Pharmacy Technician (CPhT) and Certified Compounded Sterile Preparation Technician (CSPT)Active pharmacy technician license/registration inTexas, in good standing2 years of sterile compounding experience in a 503A / 503B / hospital IV room settingDemonstrated proficiency in aseptic technique with current media-fill and gloved fingertip qualification. Working knowledge of USP <795>, <797>, and <800>Strong pharmaceutical calculation skills and attention to detailAbility to follow written SOPs precisely without deviation

• Experience with automated compounding devices, pump-fillers, or semi-automated filling equipment
• Experience in an FDA-registered outsourcing facility under cGMP
• Familiarity with pharmacy management systems and electronic batch records

Extended periods of standing and repetitive fine-motor work at a hoodAbility to lift up to [35] lbsWork in a controlled cleanroom environment requiring full garb; no cosmetics, jewelry, or artificial nailsExposure to hazardous drugs with appropriate engineering and PPE controlsMust pass fit-testing for respiratory protection where applicable

All Company policies and procedures are subject to change without notice based on business needs. This includes, but is not limited to, the locations where we hire remote, hybrid, or onsite employees.