Administrative Skills, Certified Pharmacy Technician (CPhT), Cleanroom, Customer Support/Service, HIPAA (Health Insurance Portability and Accountability Act), Inventory Management, Lift/Move 30 Pounds, Maintain Compliance, Operational Support, Operations, Order Supplies, Pharmacy, Physical Demands, Prescription Drugs, Prescription Filling, Privacy Controls, Quality Assurance, Quality Management, Regulatory Compliance, Standard Operating Procedures (SOP), Technical Writing, Writing Skills
Description
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 <795> and USP <797> 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 <800> 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 <795>, <797>, and <800> 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.