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 Sterile Products departmental processes to ensure that the procedures reflect changes in operational procedures and the current standard of practice.
- Participate in developing Sterile Products procedures to ensure the pharmacy department meets all legal, accreditation, and certification requirements posted by the FDA, Board of Pharmacy, Board of Health, DEA, CMS, USP 797, USP 800, and Joint Commission
- Conducts regular audits of Pharmacy Sterile products related documentation
- Identifies deficiencies related to inadequate or incomplete record-keeping and documentation
- Performs audits identified by Pharmacy management as required to meet regulatory or compliance standards; providing data analysis and summary
- Personnel Training and Education:
- Oversees the training of personnel in all activities pertaining to; sterile compounding, the handling of hazardous drugs, and the maintenance of sterile compounding environments
- Assists with onboarding and orientation of new pharmacy associates
- Ensures ongoing competency assessment as outlined by USP 797/800 and/or state and federal regulations
- In concert with Pharmacy Leadership, contribute to developing or revising existing departmental Sterile products related policy and procedures related to USP 797/800.
Job Requirements
- Associate's Degree required.
- Minimum of three (3) to five (5) years experience required.
- Hospital Pharmacy and IV room experience required.
- Florida Pharmacy Technician licensure required.
- Certified Pharmacy Technician and Bachelor's degree preferred.
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