The Sterile Compounding Technician prepares and admixtures sterile pharmaceutical products in a highly controlled, regulated 503B environment. This role requires working in aseptic ISO 7 cleanrooms and ISO 5 workspaces while strictly adhering to FDA regulations, current Good Manufacturing Practices (cGMP), and United States Pharmacopeia (USP) standards. The technician maintains an organized cleanroom, manages product inventory and supplies, and collaborates closely with the pharmacy team to ensure full compliance with standard operating procedures and regulatory requirements.

• Prepare and compound sterile pharmaceutical products in accordance with FDA regulations, cGMP, USP <797>, and pharmacy state board guidelines.
• Apply aseptic technique consistently while working inside ISO 7 cleanrooms and ISO 5 workspaces to ensure the sterility and integrity of all products.
• Maintain accurate and complete manufacturing records and documentation in compliance with cGMP, FDA, USP, and state regulatory requirements.
• Operate and monitor technical, computerized compounding and filling equipment, ensuring all processes meet established quality standards.
• Perform weighing, mixing, and associated activities for sterile compounding, following established formulas, procedures, and batch records.
• Record, review, and monitor results for pharmaceutical quality assurance testing to ensure potency, quality, purity, integrity, sterility, and endotoxin content standards are consistently met.
• Carry out device and equipment sterilization processes under pharmacist supervision, following validated procedures and documentation requirements.
• Monitor inventory levels for chemicals, compounds, devices, containers, and other materials, and initiate re-orders for low or expiring inventory.
• Verify and stage materials for use in batch compounding to ensure correct identity, quality, and suitability prior to use.
• Support daily, weekly, and monthly cleaning of the cleanroom and related environments using appropriate disinfectants and techniques.
• Complete end-of-batch reconciliation and count verification to ensure all materials and finished units are accounted for and documented.
• Successfully complete initial and ongoing aseptic technique competency evaluations in accordance with policies and procedures.
• Participate in and successfully complete product validations and complex media fill verifications as required for ongoing qualification.
• Maintain a highly organized cleanroom environment, including proper storage, labeling, and handling of all materials and equipment.
• Collaborate with the pharmacy and production team to ensure adherence to standard operating procedures and continuous improvement of processes.
• Perform other duties as assigned by the department or pharmacy leadership to support safe, compliant, and efficient operations.

• Demonstrated knowledge of current Good Manufacturing Practices (cGMP) and FDA regulations related to sterile pharmaceutical compounding.
• Familiarity with United States Pharmacopeia (USP) standards, including USP <797> Pharmaceutical Compounding – Sterile Preparations.
• Proficiency in aseptic technique and working in controlled environments such as ISO 7 cleanrooms and ISO 5 workspaces.
• Prior sterile compounding experience in a hospital, GMP, or cleanroom environment, including experience with IV antibiotics, total parenteral nutrition (TPNs), chemotherapy, or similar sterile products.
• Ability to operate and monitor technical, computerized compounding and filling equipment safely and accurately.
• Strong attention to detail to consistently meet standards for potency, quality, purity, integrity, sterility, and endotoxin content.
• Ability to accurately weigh, mix, and document sterile compounded products in accordance with batch records and procedures.
• Competence in maintaining thorough, compliant documentation and manufacturing records in line with regulatory requirements.
• Capability to perform and support equipment and device sterilization processes under pharmacist supervision.
• Willingness and ability to complete initial and ongoing aseptic technique competency evaluations and media fill validations.

• Experience working in a 503B outsourcing facility or similar highly regulated sterile manufacturing environment.
• Familiarity with cleanroom cleaning procedures, including daily, weekly, and monthly disinfection schedules and techniques.
• Comfort working with computerized systems for production, documentation, and equi