QA & Operations Pharmacy Technician

Biote; Tampa (FL); On-site; USD 60,000 - 90,000; Full time

Job summary

Biote is seeking a Quality Assurance & Operations Pharmacy Technician to bridge regulatory compliance with daily pharmacy operations in a 503A compounding setting. You will author and maintain SOPs, manage Simplifi797, and support audits while hands-on compounding, filling, and shipping duties keep the workflow running.

The role requires a licensed Florida Pharmacy Technician with 2–3 years in compounding, and strong writing and documentation skills to ensure GMP-like discipline in a

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.

Responsibilities

• Quality Assurance & Compliance: Draft, revise, and maintain SOPs, work instructions, and quality logs to ensure regulatory compliance.
• Quality Assurance & Compliance: Build and administer the Simplifi797 site for cleanroom operations.
• Quality Assurance & Compliance: Develop training materials and support hands-on training and competency assessment of pharmacy technicians.
• Quality Assurance & Compliance: 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.
• Pharmacy Operations & Fulfillment: Accurately prepare, label, and fill prescriptions for pharmacist verification.
• Pharmacy Operations & Fulfillment: Package, verify, and ship prescriptions securely, maintaining cold-chain integrity where required.
• Pharmacy Operations & Fulfillment: Receive and maintain inventory; order supplies.
• Pharmacy Operations & Fulfillment: Support general facility operations, customer service, and administrative tasks as the pharmacy scales.

Skills

Technical writing

SOP drafting

Quality logs

Documentation

Pharmacy workflow

Tools

Simplifi797

Job 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.

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.