Nuclear Pharmacy Quality Assurance Technician

2 weeks ago


Morgantown, West Virginia, United States SOFIE Full time
Title: Nuclear Pharmacist I
Department: Network Operations, Pharmacy
Reports To: Pharmacist-in-Charge and Facility Manager

Overview

The Nuclear Pharmacist I is responsible for the compounding and dispensing of radiopharmaceuticals. This position requires working in a controlled environment with potential exposure to radiation.

This role is crucial to the Quality Assurance Program within SOFIE and involves close collaboration with the Quality Assurance division at the site level.

Key Responsibilities
• Execute tasks related to the compounding, dispensing, and distribution of radiopharmaceuticals, including data entry for end-of-day and daily dose management reports.
• Conduct synthesis, quality control, and quality assurance of FDG and NaF, which includes reagent preparation.
• Maintain compliance with USP regulations and state pharmacy requirements; ensure personal licensure remains in good standing.
• Adhere to all standard operating procedures (SOPs) and regulations, including 21 CFR Parts 211 and 212, ensuring a state of cGMP control.
• Follow aseptic procedures in accordance with internal protocols, customer specifications, and FDA regulations.
• Uphold safety standards related to radiation and laboratory environments, including managing chemical or radioactive spills.
• Complete necessary cGMP documentation and assist in Quality Assurance activities, including:
o Investigations
o Corrective and Preventative Actions
o Deviations
o Out of Specifications
o Manufacturing and QC Records
o Logbooks
• Draft and review internal procedures.
• Collaborate with site QA to review and release batch records as necessary.
• Initiate and manage change controls, maintaining and reviewing site-specific procedures.
• Monitor the metrology program in conjunction with site QA, ensuring timely maintenance and calibration of equipment.
• Address customer and patient complaints in partnership with site QA to identify root causes and resolve issues effectively.
• Provide on-site QA oversight for manufacturing and QC activities, identifying non-compliance and proposing solutions.
• Deliver quality customer service regarding radiopharmaceuticals to healthcare professionals and clients.
• Train and supervise nuclear pharmacy technicians, maintaining accurate training documentation.
• Participate in corporate and site-level meetings as required.
• Perform additional duties as assigned.
Qualifications

• A B.S. or Pharm.D. from an accredited pharmacy institution is required; nuclear certification is preferred.

• A state license is required (to be obtained post-hire if applicable). Experience in nuclear pharmacy, Positron Emission Tomography, and radiation safety is advantageous.

• Proficient in reading, analyzing, and interpreting business publications, professional journals, and regulatory guidelines.
• Capable of writing reports, business correspondence, and procedural manuals.
• Effective in presenting information and addressing inquiries from various stakeholders, including management and regulatory bodies.
• Strong analytical skills to define problems, gather data, and draw valid conclusions.
• Excellent management and interpersonal skills are essential.
• Proficient in Microsoft Office applications; familiarity with Pinestar or similar pharmacy software is preferred.
• Detail-oriented, responsible, and organized, with the ability to work collaboratively in a team setting.
• Flexibility to work various shifts and weekends is required.
• Strong communication skills with a focus on professionalism and attention to detail in a fast-paced environment.
• Ability to lift approximately 50 lbs is necessary.
• Willingness to travel up to 10% is required.

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