Quality Assurance Lead Pharmacy Technician

Nemours Children's Health is seeking a Quality Assurance Lead Pharmacy Technician to join our Pharmacy team in Orlando, Florida.

This position is a Monday to Friday, 8 am to 4:30 pm, with flexibility depending on regulatory requirements.

There is a weekend rotation every 4 weeks (once a month).

The Quality Assurance Lead Pharmacy Technician, in concert with Pharmacy Leadership, provides input and technical expertise in the planning, development, implementation, and evaluation of pharmacy systems to ensure the integrity, adherence, and safety of the services provided by the department.

This position directly affects the Pharmacy Department's ability to comply with all relevant regulations and develop, maintain, and coordinate quality and safety programs.


* Carries out rules and regulations pertaining to the pharmacy department's professional policies and ensures compliance with State and Federal regulations.


* Conduct environmental and personnel sampling components of the overall quality management program for sterile compounding as outlined by regulatory bodies and USP 797, including but not limited to:
+ Gloved Fingertip Sampling (GFS)
+ Media-Fill Testing (MFT)
+ Viable air sampling (VAS), and
+ Environmental Surface Sampling (SS)


* Ensures that the sterile compounding environments and personnel work practices reflect relevant regulatory requirements and current pharmacy practice standards


* Ensures that each area related to sterile product preparation meets the classified air quality standard appropriate for the activities to be conducted in that area and that the ISO classified areas are located, operated, maintained, monitored, and certified to have appropriate air quality.


* Ensures cleanroom environments maintain a state of control via:
+ Environmental cleaning when necessary
+ Monitoring for completion of the daily and monthly surface cleaning and disinfection tasks
+ Environmental monitoring of Pressure, Temperature, and Humidity in sterile compounding areas
+ Daily review of Simplifi 797
+ Auditing expected processes
+ Ensuring that any person who enters the sterile compounding area maintains the quality of the environment
+ Following up to ensure that corrective actions are taken if problems, deviations, failures, or errors are identified.


* Partners with the Operations and Technician Managers to monitor and ensure Sterile Products practice conforms to the Pharmacy Standard Operating Procedures and Reliable Methods for the appropriate and efficient preparation and utilization of sterile pharmaceutical products within Nemours Children's Hospital (NCH), including:
+ Monitor and ensure the physical appearance, functions, safety, and staff behavior performance in Sterile Products processing conforms to NCH standards
+ Develop, review, and update Standard Operating Procedures of...