Key Responsibilities
Leadership & Team Management: Provide direct supervision, workflow oversight, scheduling support, onboarding assistance, and competency evaluations for sterile compounding personnel while fostering a culture of quality, safety, and accountability.
Sterile Operations & Technical Oversight: Verify patient-specific prescriptions, master formulation records, and compounded lot documentation. Perform visual inspections, weight verification checks, and technical dosage calculations to ensure accuracy and compliance.
Cleanroom & Equipment Governance: Support cleanroom readiness, aseptic operating conditions, and equipment maintenance routines, including analytical balances, scales, and electronic measurement devices. Monitor chemical and pharmaceutical inventories for proper storage conditions, potency requirements, and expiration tracking.
Regulatory Compliance & Standards Enforcement: Ensure adherence to United States Pharmacopeia (USP) compounding standards, including USP <795>, USP <797>, and USP <800>, Current Good Manufacturing Practice (cGMP) regulations under 21 CFR Part 211, Food and Drug Administration (FDA) 503B guidance, and State Board of Pharmacy requirements.
Environmental Monitoring & Quality Assurance: Support environmental monitoring programs, cleanroom air quality testing, and microbiological surface sampling. Assist with root-cause investigations and development of Corrective and Preventive Action (CAPA) plans related to environmental or compounding deviations.
Staff Education & Competency Validation: Develop and deliver training programs for sterile compounding personnel focused on aseptic technique, garbing and gowning validation, hazardous drug handling, and regulatory compliance.Audit Readiness & Standard Operating Procedures (SOPs): Author, review, and maintain technical Standard Operating Procedures (SOPs). Support regulatory inspections and ensure operational documentation remains audit-ready.
Required Qualifications
Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy degree from an accredited pharmacy school
Active Florida Pharmacist license in good standing with the State Board of Pharmacy
1+ years of leadership or supervisory experience in a sterile compounding, specialty pharmacy, or pharmaceutical production environment
Strong technical knowledge of USP <797> sterile compounding standards, USP <800> hazardous drug handling requirements, and cGMP quality systems
Strong proficiency in pharmaceutical calculations, sterile dosage preparation, and aseptic technique validation
Exceptional attention to detail, analytical problem-solving, project management, and team leadership skills within a high-volume environment