Nuclear Pharmacist I

Essential Duties And Responsibilities

• Perform the duties associated with compounding, dispensing, and distribution of radiopharmaceuticals, including data entry with Pinestar for end-of-day reports and daily dose management reports.
• Perform the duties associated with synthesis, quality control, and quality assurance of FDG and NaF, including reagent preparation.
• Ensure compliance with USP , , proposed regulations, or other state pharmacy requirements as applicable, at the site level; maintain personal license in good standing through applicable state laws.
• Ensure compliance to all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Parts 211 and 212 requirements, by adhering to SOFIE’s quality management system and maintain a state of cGMP control at the site.
• Ensure aseptic operations follow internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations.
• Ensure compliance with radiation and laboratory safety of the site, including the ability to address chemical or radioactive spills and reporting.
• Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to: Investigations, Corrective and Preventative Actions, Deviations, Out of Specifications, No or Atypical Yields, Manufacturing and QC Records, Logbooks.
• Write and review internal procedures.
• With site QA, review and release batch records as applicable.
• Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site specific procedures relative to their job functions.
• With site QA, monitor the metrology program at the site. Ensure that equipment is appropriately maintained, calibrated/recalibrated, or validated/revalidated in a timely manner.
• With site QA, monitor customer/patient complaints to determine the possible root causes.
• Provide on-the-floor QA oversight of manufacturing, QC, and other cGMP activities. Identify non-compliance problems and propose solutions. Effectively interact with other functional personnel and resolve quality related issues on the spot whenever possible.
• Provide quality customer service associated with radiopharmaceuticals to physicians, healthcare workers, customers, etc. as needed.
• Train and supervise nuclear pharmacy technicians and maintain accurate training records.
• Attend corporate and site level meetings as applicable.
• Perform other duties as assigned.

Qualifications

• B.S. or Pharm.D. from an accredited pharmacy school required; nuclear certification preferred.
• State license required (to be obtained post-hire if applicable).
• Background in nuclear pharmacy, Positron Emission Tomography, radiation safety and/or familiarity with cyclotron processes preferred.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations required.
• Ability to write reports, business correspondence, and procedure manuals required.
• Ability to effectively present information and respond to questions or complaints from groups of managers, clients, customers, the public required, or regulatory agencies required.
• Ability to define problems, collect data, establish facts, and draw valid conclusions required.
• Strong Management And Interpersonal Skills Required.
• Proficient in all MS Office applications required. Proficiency in Pinestar or other pharmacy applications preferred.
• Ability to be detail-oriented, responsible, dependable, patient, organized, professional and work in a team environment required.
• Ability to work various shifts and weekends required.
• Ability to communicate professionally with colleagues and customers, have excellent attention to detail, and be dependable and responsible in a fast-paced, highly technical environment required.
• Ability to lift ~50lbs required.
• Up to 10% travel required.