Sterile Compounding Pharmacist
2 days ago
McKinney
Job Description Job Description Title: Sterile Compounding Pharmacist Location: Mckinney, TX Reports To: Director of Pharmacy Operations Position Summary The Sterile Compounding Pharmacist is responsible for performing and overseeing sterile compounding activities in compliance with USP <797>, USP <800> (as applicable), Texas State Board of Pharmacy regulations, and internal Standard Operating Procedures (SOPs). This role ensures the safe, accurate, and timely preparation of compounded sterile preparations (CSPs) for individually identified patients under prescription, while maintaining the highest standards of aseptic technique, documentation, and patient safety. Key Responsibilities Compounding & Verification • Compound and supervise the compounding of sterile preparations (e.g., Mostly Injectables) in accordance with USP <797> and FDA Insanitary conditions requirements., • Verify accuracy of formulas, calculations, ingredients, labeling, and packaging for all compounded sterile products., • Ensure beyond-use dates (BUDs) are assigned appropriately per USP guidelines and stability data., • Perform final product checks for sterility, clarity, and labeling before release., • Maintain compliance with all applicable federal, state, and local regulations, including Texas Administrative Code §291 (Pharmacy Rules)., • Adhere strictly to internal SOPs and report/document any deviations or non-conformances., • Ensure proper environmental monitoring, cleaning, and disinfection of cleanroom and primary engineering controls (PECs)., • Demonstrate and maintain competency in garbing, hand hygiene, and aseptic manipulations per USP <797>., • Maintain certification through glove fingertip sampling and media fill testing at required intervals., • Accurately complete compounding logs, batch records, and patient prescription records., • Document and review cleaning logs, equipment calibration records, and training records., • Provide training, oversight, and evaluation of pharmacy technicians engaged in sterile compounding., • Serve as a subject matter expert for sterile compounding, mentoring junior pharmacists and technicians., • Ensure proper handling of hazardous drugs (if applicable) in compliance with USP <800>., • Report and document adverse events, errors, or near misses in accordance with pharmacy policies., • Education: Doctor of Pharmacy (PharmD), • Licensure: Current and active Pharmacist license in the State of Texas, in good standing. Other State Licenses is a plus, • Experience:, • Minimum 2 years of sterile compounding experience in a hospital or compounding pharmacy setting., • Experience with USP <797>, <800>, and applicable Texas Board of Pharmacy regulations., • Skills/Competencies:, • Strong knowledge of aseptic technique, cleanroom procedures, and compounding equipment., • Excellent attention to detail and organizational skills., • Ability to work independently and collaboratively in a fast-paced environment., • Ability to work in ISO-classified cleanroom environments while wearing full PPE., • Ability to stand for extended periods and perform repetitive aseptic manipulations., • Certification in Sterile Compounding (e.g., NABP/PCAB, BPS Compounded Sterile Preparations Specialty)., • Experience with human sterile compounding., • Prior experience in a 503A or 503B compounding environment., • Prior experience with FDA audits., • Experience with LifeFile is a plus., • Experience with PK Compounder is a plus. Benefits: • 401(k), • 401(k) matching, • Dental insurance, • Employee discount, • Health insurance, • Paid time off