Quality Assurance Coordinator

About Hephaestus:

At Hephaestus, we work with the latest technologies to shape a product vital to millions of people's daily lives. Join our high-energy, fast-paced startup environment, and enjoy a casual culture with generous PTO and benefits!

We are seeking a Quality Assurance Coordinator in the state of Florida to join our team and play a critical role in advancing our sterile compounding pharmacy initiatives. This role will be instrumental in establishing and managing a sterile compounding facility in Florida, ensuring the highest standards of quality, compliance, and operational excellence.

This position is located on-site at our facility in Doral, FL.

Position Overview

Working with the Quality Assurance Manager to plan, organize, direct, and lead the personnel and work process of the quality improvement program. Also works on training aspects of the organization and other projects as assigned. Responsible for quality improvement activities, audits, training, documentation, compliance monitoring, and sterile compounding quality initiatives.

Responsibilities:

• Monitors the development and implementation of the quality improvement program.
• Performs under minimal supervision with accountability for specific goals/objectives.
• Measures and evaluates attainment of results.
• Performs internal audits and chart audits for all departments.
• Assure improvement activities are documented and reported appropriately.
• Facilitates quality improvement activities, training programs, data analysis, and outcome measurement.
• Knowledgeable in Federal and State regulatory requirements governing sterile compounding.

Day to Day duties of the position

• Compound sterile and non-sterile medications
• Perform daily inventory counts, file paperwork, and stock inventory in sterile department
• Troubleshoot equipment and basic software issues
• Document compounding related activities and adhere to all QA responsibilities
• Create and foster a positive team dynamic
• Fill, pack, and ship prescription orders in accordance with Standard Operating Procedures (SOPs).
• Daily monitoring of Cleanroom responsibilities.
• Perform other tasks as needed.

Required Qualifications

• Current Pharmacy Technician license or certification in good standing
• Experience with Pharmacy Management Systems (Pharmetika and Pestle a plus)
• Three years experience working as a pharmacy technician
• USP 795 & 797 Training

Preferred Qualifications

• Sterile experience
• Previous warehouse or compounding pharmaceutical experience
• Familiarity with FDA, USP, or Board of Pharmacy standards

Work Environment

• Pharmacy warehouse setting
• Exposure to refrigerated and controlled room temperature areas
• Moderate noise level typical of warehouse operations
• High level of regulatory oversight and documentation requirement s

Physical Requirements

Employees must be able to stand and walk for extended periods, lift up to 50 pounds occasionally, perform repetitive motions, work in temperature-controlled and refrigerated environments, and maintain attention to detail while handling pharmaceutical products in compliance with regulatory requirements.

Company Offers

• Pay range: $32.00-$36.00 per hour
• Generous PTO and Sick Time
• Medical/Rx Insurance
• Dental & Vision Insurance
• 10 Recognized Company Holidays
• Impactful rewarding work as part of a fast-growing brand helping thousands of people every day