Radiopharmacist/QA Officer - Cyclotron (Rotator Call-In)

Company: Queen's Health System
Location: Honolulu
Posted on: January 12, 2022

Job Description:

Responsibilities

I. JOB SUMMARY/RESPONSIBILITIES:

• In collaboration with the Radiochemist, responsible for the operations of the cyclotron facility including isotope production, and synthesis. Ensures operations comply with regulatory requirements and the policies and procedures of The Queen's Medical Center (QMC).
• In collaboration with Radiation Safety Officer, ensures compliance with radiation safety program and policies in the manufacture and distribution of quality positron emitting radiopharmaceuticals. Coordinates and leads all quality assurance programs in performance metrics and guidelines within the Cyclotron Lab specific to the production of F18 Fludeoxyglucose based on the QMC (Abbreviated New Drug Application) ANDA.
• Applies quality assurance (QA) processes and procedures at the site level to ensure product quality and regulatory compliance with 21 CFR Part 212 and related regulations and regulatory guidance.
• Serves as the Quality Assurance Officer of the cyclotron facility.II. TYPICAL PHYSICAL DEMANDS:
  
  • Essential: standing, walking, finger dexterity, seeing, hearing, pushing/pulling up to 50 pounds of force; frequent gripping of an object.
  • Frequent: speaking; reaching below shoulder level; repetitive arm/hand motions.
  • Occasional: sitting, stooping/bending, kneeling, squatting, twisting body, lifting and carrying weight of 20 pounds up to 30 pounds; reaching above and at shoulder level.III. TYPICAL WORKING CONDITIONS:
    
    • Not substantially subjected to adverse environmental conditions.
    • Work involves handling hazardous material.IV. MINIMUM QUALIFICATIONS:A. EDUCATION/CERTIFICATION AND LICENSURE:
      
      • Current Hawaii State license as a Pharmacist.
      • Completion of a Nuclear Pharmacy program.
      • Recognition as a Board Certified Nuclear Pharmacist by the Nuclear Regulatory Commission (NRC) under The Queen's Medical Center facility preferred.B. EXPERIENCE:
        
        • Two (2) years experience as a radio-pharmacist at a cyclotron (radiopharmaceutical-PET) facility preferred.
        • Experience to demonstrate the following:o Knowledge and ability of cyclotron production of radioisotopes.
          o Knowledge and familiarity with PET cyclotron requirements including GMP and ANDA compliance issues.
          o Proficient in a variety of automated and non-automated synthesis procedures and processes.
          o Proficient in a variety of computer and lab equipment.
          
          • Ability to initialize and maximize system performance for both cyclotron and synthesis units preferred.
          • Cyclotron lab administration experience preferred.
          • Research experience preferred.
          • CTI cyclotron experience preferred.
          • CTI synthesis module experience preferred.Equal Employment Opportunity
            
            Equal Opportunity Employer / Disability / Vet
            
            #queens4

Keywords: Queen's Health System, Honolulu , Radiopharmacist/QA Officer - Cyclotron (Rotator Call-In), Other , Honolulu, Hawaii