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Pharmacist Quality Assurance

Location:
Southaven, MS
Salary:
can talk about salary
Posted:
May 10, 2021

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Resume:

William Boerger

386-***-**** (Mobile)

E-mail address: admabb@r.postjobfree.com

Hurst, TX 76053

SUMMARY

Nuclear Pharmaceutical professional with significant experience in compounding and dispensing radiopharmaceuticals. Exceptional attention to detail and well-versed in the protocols involved with handling these types of materials. Able to perform all the duties connected with the successful completion of this position.

Specific Qualifications

Performs all 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 responsibilities related to synthesis, quality control, and quality assurance of FDG and NaF, including reagent preparation.

Compliance with all regulations and SOP, as well as other state pharmacy requirements as applicable. Maintains licenses in good standing.

Follows procedures in 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, and trained in handling chemical or radioactive accidents, if they occur.

Able to perform corrective and preventative actions.

Works closely with the Quality Assurance people and external customers to provide a good experience for both.

Site Qualified Person (QP)

Pharmacist in Charge (PIC

EXPERIENCE

Staff Pharmacist

Sofie- Dallas, TX

May 2018-Feb 2020

Perform all duties associated with compounding radiopharmaceuticals.

Compounds, dispenses, and distributes radiopharmaceuticals and enters data into Pinestar for end-of-day reports and daily dose management reports.

Performs synthesis, quality control, and quality assurance of FDG and NaF, including reagent preparation.

Ensures compliance with USP <797>, <823>, proposed <825> regulations, or other state pharmacy requirements as applicable,

Maintains personal license in good standing through applicable state laws.

Complies with all applicable standard operation procedures (SOPs) and regulations, including 21 CFR Parts 211 and 212 requirements, by adhering to quality management systems and maintain a state of cGMP control at the site.

Ensures that all aseptic operations follow internal procedures (gowning, cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations.

Complies with radiation and laboratory safety of the site, including the ability to address chemical or radioactive spills and reporting.

Completes cGMP documents as required and assists 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, and Logbooks.

Writes and review internal procedures.

With site QA, reviews and releases batch records as applicable.

With site QA, monitors the metrology program at the site. Ensures that equipment is appropriately maintained, calibrated/recalibrated, or validated/revalidated promptly.

With site QA, monitors customer/patient complaints to determine possible root causes. Works with customers to ensure their concerns are addressed, quality standards are met, and issues are resolved promptly and effectively.

Provides on-the-floor QA oversight of manufacturing, QC, and other cGMP activities. Identifies non-compliance problems and propose solutions. Energetically interacts 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.

Nuclear Pharmacist

General Electric-Temple TX

Aug 2015 - Apr 2018

Performs duties associated with compounding radiopharmaceuticals

Nuclear Pharmacist

Triad Isotopes - Orlando

Sep 2014 - May 2015

Calculated and planned daily dosing schedules.

Manufacture and distribution of SPEC radionuclides

Coordination of ordering and distribution of doses

Pharmacy Technician

Zevacor Molecular - Springfield/St. Louis

Jun 2013-Sep 2014

Calculation and planning of daily dosing schedules

Manufacture and distribution of SPEC radionuclides

Coordination of ordering and delivery of doses

Rotate between Springfield and St. Louis

Pharmacist in Charge

IBA/Eastern Isotopes - Sanford, Florida

2000 – June 2013

Calculation and planning of daily dosing schedules

Manufacture and distribution of PET radionuclides (F-18 FDG, F-18 NaF, etc.)

Coordination of ordering and distribution of doses

On-call rotation

Customer Support

Manage the Radiation Safety Program

EDUCATION

BS - Pharmacy - Purdue University - West Lafayette, Indiana

LICENSURE - Registered Pharmacist

Florida (PS 27293 & NP 137)

Maryland (12689)

West Virginia (RP0006335)

Ohio (Rph0332695957-3)

Texas (41184)

New Jersey (28R102996700)

Missouri (007035)

Louisiana (PST.019550)

Sterile Compounding class



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