Quality Assurance Lead Pharmacy Technician jobs in United States
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Nemours Children's Health · 2 weeks ago

Quality Assurance Lead Pharmacy Technician

Nemours Children's Health is an internationally recognized children’s health system. The Quality Assurance Lead Pharmacy Technician will provide 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.

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H1B Sponsor Likelynote

Responsibilities

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
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

Qualification

Florida Pharmacy Technician licensureCertified Pharmacy TechnicianHospital Pharmacy experienceSterile compounding proceduresQuality management programsPersonnel trainingRegulatory complianceDocumentation audits

Required

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

Preferred

Certified Pharmacy Technician and Bachelor's degree preferred

Company

Nemours Children's Health

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Nemours Children's Health is committed to improving the health of children.

H1B Sponsorship

Nemours Children's Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
2021 (4)
2020 (2)

Funding

Current Stage
Late Stage
Total Funding
$10.5M
Key Investors
National Institutes of Health
2021-09-21Grant· $10.5M

Leadership Team

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Mark Mumford
EVP, Chief Operating Officer, Nemours Children's Health
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Kevin Haynes
Chief Privacy Officer
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Company data provided by crunchbase