Certified Sterile Compounding Technician

Job Description

Job Description

Description:

Role Summary

The Sterile Compounding Technician is a registered pharmacy technician responsible for preparing low-, medium-, and high-risk sterile compounded products in a controlled, cleanroom environment. Working under the direct supervision of the Sterile Compounding Pharmacist and Pharmacist-in-Charge, this role demands a precise, detail-oriented professional who is fully committed to patient safety, product quality, and strict regulatory compliance. The Sterile Compounding Technician is responsible not only for accurately preparing sterile formulations but also for maintaining the integrity of the cleanroom environment, upholding USP 797 and 800 standards, and ensuring meticulous management of inventory and batch records.

1. Sterile Product Compounding

• Compound low-, medium-, and high-risk sterile preparations in accordance with physician orders and Master Formulation Records, including sterile injections, ophthalmics, inhalation solutions, suspensions, and freeze-dried powders.

• Consistently meet established standards for strength, quality, purity, integrity, sterility, and endotoxin content for all sterile preparations.

• Follow all applicable company Standard Operating Procedures (SOPs), NJ Board of Pharmacy regulations, and USP 797 and 800 guidelines without exception.

• Exercise meticulous attention to detail at every stage of the compounding process to safeguard patient safety and product integrity.

2. Batch Records & Quality Control

• Ensure the accuracy and completeness of all compounding batch records, including documenting lot numbers, manufacturers, and quantities of all components, supplies, and equipment used.

• Follow all instructions outlined in the Master Formulation Record precisely and without deviation.

• Perform and document all required Quality Control (QC) checks and results in accordance with applicable SOPs.

• Report any deviations, discrepancies, or quality-related events to the supervising pharmacist immediately.

3. Clean Room Maintenance & Environmental Monitoring

• Perform daily, weekly, and monthly cleaning of the sterile compounding environment in strict accordance with company SOPs.

• Conduct environmental monitoring and sampling of the clean room, including surface sampling, air sampling, and viable particle counts, as required by USP 797 and company protocols.

• Maintain ISO-classified clean room conditions at all times; report any environmental excursions or equipment anomalies to the supervising pharmacist promptly.

• Ensure proper gowning, garbing, and aseptic technique are maintained throughout all clean room activities.

4. Inventory Management

• Notify RPh of inventory levels for all sterile compounding chemicals, APIs, and components; initiate re-ordering for low-inventory or approaching-expiry items in a timely manner.

• Conduct monthly checks of all inventory for expired or expiring chemicals and components; quarantine and document as appropriate.

• Maintain organized, accurate, and audit-ready controlled-substance inventory records at all times.