Nuclear Pharmacist I
Company: SOFIE
Location: Gilroy
Posted on: May 27, 2023
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Job Description:
Title - Nuclear Pharmacist I
Location - Gilroy, CA
Department - Network Operations, Pharmacy
Reports To - Pharmacist-in-Charge and Facility Manager
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 , , proposed 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
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.
Keywords: SOFIE, Gilroy , Nuclear Pharmacist I, Healthcare , Gilroy, California
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