QA & Operations Pharmacy Technician

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.