• Ensure compliance with all applicable federal, state, and local laws, rules, and regulations pertaining to sterile compounding
• Strong understanding of USP 797 and USP 800
• Develop new formulations and maintain existing formula worksheets according to the company?s SOPs
• Troubleshoot formulation problems and propose solutions
• Write and review compounding SOPs
• Train technicians and pharmacists in the use of PK Compounder and other pharmacy software, as well as compounding equipment and procedures.
• Compound with technicians as workflow requires
• Communicate extensively with Sterile Compounding Manager, Sterile Compounding Supervisor, and compounding technicians
• Collaborate with the Quality Department on all process improvements, actively contributes with investigations, deviations, and CAPAs
• Check compounding activity performance by technicians and release batches to the quality assurance team accordingly
• Participates in pharmacy inspections including but not limited to (FDA, NABP, DEA, state boards of pharmacy) if requested
• Assures project work and change initiatives are completed on time and executed completely
• Maintain compounding laboratory space to standard set forth in policies and procedures (e.g., LUMAC, equipment maintenance schedules, cleaning)
• Ensure compliance with company patient confidentiality requirements
• Ensure compliance with corporate policies and procedures that apply to pharmacy services
• Provide for the educational needs of pharmacy staff and patients as it pertains to the process of sterile compounding
• Assist the Sterile Compounding Manager in ensuring adequate control and documentation of controlled substances used in compounding
• Must be able to work in a variety of positions locations such as sitting, standing, squatting, kneeling, reaching, and walking, for prolonged periods of time
• Potential exposure to chemicals used in the preparation of compounds. Some chemicals are classified as hazardous and special safety precautions must be taken when working with these chemicals
• Must be able to wear required compounding safety equipment for a minimum of eight-hour periods of time when required
Job Type: Full-time
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