Overview
The Nuclear Pharmacist I will compound and dispense radiopharmaceuticals. This job involves working in a cleanroom as well as occupational exposure to radiation. While reporting into Network Operations, the Nuclear Pharmacist role is instrumental to the Quality Assurance Program within SOFIE and will work closely with the QA division at the site level.
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 <797>, <823>, proposed <825> regulations, or other state pharmacy requirements as applicable, at the site level; maintain a 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 maintaining 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. Work with the customers to ensure their concerns are addressed, quality standards are met, and issues are resolved promptly and effectively.
* 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.