Biotech and Pharmaceutical, Certified Pharmacy Technician (CPhT), Cleanroom, Data Analysis, Detail Oriented, Documentation, Emerging Technology, FDA (Food and Drug Administration), Federal Laws and Regulations, Identify Issues, Internal Audit, Lift/Move 50 Pounds, Maintain Compliance, Medications, Order Picking/Packing, Organizational Skills, Pharmacy, Quality Assurance, Quality Management, Regulatory Compliance, Regulatory Requirements, Standard Operating Procedures (SOP), State Laws and Regulations, Training Program, Warehousing
LOCATION
Miami, FL
POSTED
9 days ago
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 requirements
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