Compounding Pharmacist
Core
Provide final verification and clinical oversight of compounded sterile and non-sterile preparations, ensuring identity, strength, quality, and purity while owning quality systems for regulatory compliance.
Role type
Senior clinical pharmacist (sterile compounding)
Builds
Compounded sterile and non-sterile preparations for patients
Domain
Healthcare / Pharmaceutical compounding
Required skills
Sterile compounding expertise, Aseptic technique, USP <795>/<797>/<800> knowledge, Quality system management, Regulatory compliance, Hazardous drug handling
Preferred skills
Designated Person experience, PIC experience, QA/QC experience, FDA-registered 503B facility experience, Multi-state licensure
Technologies
USP <795>, USP <797>, USP <800>, USP <1163>, cGMP
Responsibilities
Perform final verification of all compounded preparations, Develop and approve master formulation records, Oversee environmental monitoring programs, Investigate deviations and adverse events, Support or serve as Designated Person under USP <797>/<800>, Ensure compliance with DQSA Section 503A / 503B requirements
Seniority
Senior, hands-on IC