QA & Operations Pharmacy Technician

POSITION SUMMARY The Quality Assurance & Operations Pharmacy Technician is a senior, specialist-level role that bridges regulatory compliance and daily pharmacy operations within a 503A compounding pharmacy. The position divides its time between building and maintaining the pharmacy’s quality management system — SOP and work-instruction authoring, Simplifi797 administration, and audit readiness — and performing hands-on technician duties including sterile and non-sterile compounding, filling, and shipping. It suits an experienced, licensed technician who can work independently in a fast-paced, growth-stage environment and move fluidly between quality-systems work and the compounding floor. KEY RESPONSIBILITIES Quality Assurance & Compliance • Draft, revise, and maintain Standard Operating Procedures (SOPs), work instructions, and quality logs to ensure compliance with applicable regulatory standards. • Build and administer the Simplifi797 site for cleanroom operations. • Develop training materials and support hands-on training and competency assessment of pharmacy technicians. • Maintain continuous audit readiness — ensuring master formulation records, compounding logs, and quality records are complete and reviewed. Pharmacy Operations & Fulfillment • Compound sterile and non-sterile preparations in accordance with USP standards and facility SOPs. • Accurately prepare, label, and fill prescriptions for pharmacist verification. • Package, verify, and ship prescriptions securely, maintaining cold-chain integrity where required. • Receive and maintain inventory; order supplies. • Support general facility operations, customer service, and administrative tasks as the pharmacy scales. REQUIRED QUALIFICATIONS • Current state Registered Pharmacy Technician license (Florida for this position). • 2–3 years of experience in a compounding pharmacy (sterile and/or non-sterile). • Working knowledge of USP and USP standards. • Strong technical-writing skills, with experience drafting SOPs, work instructions, or quality logs. • Proficiency with Simplifi797 or equivalent compliance-management software. • Solid understanding of pharmacy workflow and prescription processing. PREFERRED QUALIFICATIONS • USP knowledge. • CPhT certification (PTCB or equivalent). • Prior experience supporting audits or inspections in a 503A / 503B setting. Docusign Envelope ID: 54F2522B-3B73-83B4-8389-F8E8BBE4A5D8 REGULATORY & COMPLIANCE EXPECTATIONS All duties are performed under a licensed pharmacist’s supervision and in compliance with: • Governing State Board of Pharmacy regulations (Florida Board of Pharmacy for this position). • USP , , and compounding standards. • DEA and controlled-substance requirements, where applicable. • DSCSA receiving and recordkeeping, where assigned. • HIPAA privacy and security rules. • Facility SOPs (compounding, dispensing, controlled substances, cold-chain, HIPAA, inspection readiness). PHYSICAL REQUIREMENTS & WORKING CONDITIONS • Cleanroom environment requiring adherence to garbing and personal protective equipment (PPE) protocols. • Ability to stand for extended periods and lift up to 30 lbs. • Frequent use of computers and pharmacy equipment.