SOFIE
Floating Nuclear Pharmacist
SOFIE, Somerset, Kentucky, United States, 42501
Title | Floating Nuclear Pharmacist
Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.
Department | Operations
Reports To | Dotted-line to Corporate PIC
Overview
The Staff Nuclear Pharmacist – Float will compound and dispense radiopharmaceuticals to support facilities with RPh staffing shortages due to PTO, leave etc.
Essential Duties and Responsibilities
While on site, the float staff nuclear pharmacist will perform the same duties as a full-time staff nuclear pharmacist.
§ Perform the duties associated with manufacturing, 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 radiopharmaceuticals, including reagent preparation.
§ Ensure compliance with USP , , proposed regulations, or other state pharmacy requirements as applicable, at the site level.
§ 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.
§ Ensure compliance to SOFIE’s exception documentation program (Change Control, Deviation, NAY, OOS, and CAPA).
§ With site QA, review and release batch records as applicable.
§ 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 other nuclear pharmacists and nuclear pharmacy technicians and maintain accurate training records.
§ Perform other duties as assigned.
Qualifications
§ B.S. or Pharm.D. from an accredited pharmacy school required; nuclear certification preferred. o Multiple State licenses 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, and professional required.
§ Approximately 50-75% travel required
Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.
Department | Operations
Reports To | Dotted-line to Corporate PIC
Overview
The Staff Nuclear Pharmacist – Float will compound and dispense radiopharmaceuticals to support facilities with RPh staffing shortages due to PTO, leave etc.
Essential Duties and Responsibilities
While on site, the float staff nuclear pharmacist will perform the same duties as a full-time staff nuclear pharmacist.
§ Perform the duties associated with manufacturing, 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 radiopharmaceuticals, including reagent preparation.
§ Ensure compliance with USP , , proposed regulations, or other state pharmacy requirements as applicable, at the site level.
§ 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.
§ Ensure compliance to SOFIE’s exception documentation program (Change Control, Deviation, NAY, OOS, and CAPA).
§ With site QA, review and release batch records as applicable.
§ 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 other nuclear pharmacists and nuclear pharmacy technicians and maintain accurate training records.
§ Perform other duties as assigned.
Qualifications
§ B.S. or Pharm.D. from an accredited pharmacy school required; nuclear certification preferred. o Multiple State licenses 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, and professional required.
§ Approximately 50-75% travel required