Technology and Automation Pharmacy Coordinator job in Greensboro at Cone Health

Overview

The Quality Assurance (QA) Pharmacy Coordinator at Moses H. Cone Memorial Hospital is a full-time role that involves leading the IV robotic sterile compounding batching and quality assurance program to support patients across the health-system. This position will report directly to the Director for sterile compounding services.

Talent Pool: Allied Health

Responsibilities

* Oversee production and staffing of sterile compounded batched drugs with automation/robotic technology• Staffing component includes verification of all IV robotic production, submissions for quality assurance testing, evaluation of results, and release of quarantine product into inventory• Provides feedback to IV robot vendor on program performance, staffing, production, opportunities for improvement• Coordinates site visits with external stakeholders on evaluation of IV robotic production and quality assurance program• Perform and/or coordinate completion of environmental monitoring and documentation, including personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts• Review sterility tests, aseptic technique qualifications, and media fill process validations• Perform and review the daily compliance verification checklist, document results, and report to immediate supervisor• New staff training supporting the IV robotic program• Collect environmental monitoring samples as necessary• Perform document review of sterile compounding batch records• Verify accuracy of labeling• Perform final disposition of batch• Verify that product test results meet specification limits• Verify that all documentation is complete• Document non-compliance and evaluate if further investigation is needed• Submit samples to the appropriate labs for chemical assay and microbial tests• Track vendor equipment calibration and maintenance records and assess for deviations• Enter test results or summaries into the pharmacy specific monthly and quarterly quality assurance report template
* Under the direct supervision, document results of deviation and compliant investigations, causal analysis, corrective actions and prevention actions• Support internal and external audits of pharmacy cleanrooms across the healthsystem• Maintain quality records, including equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, and clean room certification• Oversight of the quarantine program for batched sterile compounds• Participate in pharmacy leadership staff meetings• Precept pharmacy students, PGY1 residents, and PGY2 health-system pharmacy administration residents

Qualifications

* PharmD with an acceptable academic record and high degree of professional motivation

Sterile Compounding experience REQUIRED

* Board Certified Sterile Compounding Pharmacists (BCSCP), preferred• Previous leadership experience• Completion of PGY1/PGY2/MS Health-System Pharmacy Administration and Leadership Residency Program, or have equivalent practice experience• Minimum of 2 years experience in pharmaceutical compounding, preferred• Completion of formal sterile compounding training (e.g., professional certificate program), preferred

LICENSURE/CERTIFICATION/REGISTRY/LISTING:REQUIREDRequired - Current and active license to practice pharmacy in North Carolina, or eligible to obtain North Carolina pharmacy license within two (2) months of date of hireMaintains NC Board of Pharmacy permit if required Responsibilities • Oversee production and staffing of sterile compounded batched drugs with automation/robotic technology • Staffing component includes verification of all IV robotic production, submissions for quality assurance testing, evaluation of results, and release of quarantine product into inventory • Provides feedback to IV robot vendor on program performance, staffing, production, opportunities for improvement • Coordinates site visits with external stakeholders on evaluation of IV robotic production and quality assurance program • Perform and/or coordinate completion of environmental monitoring and documentation, including personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts • Review sterility tests, aseptic technique qualifications, and media fill process validations • Perform and review the daily compliance verification checklist, document results, and report to immediate supervisor • New staff training supporting the IV robotic program • Collect environmental monitoring samples as necessary • Perform document review of sterile compounding batch records • Verify accuracy of labeling • Perform final disposition of batch • Verify that product test results meet specification limits • Verify that all documentation is complete • Document non-compliance and evaluate if further investigation is needed • Submit samples to the appropriate labs for chemical assay and microbial tests • Track vendor equipment calibration and maintenance records and assess for deviations • Enter test results or summaries into the pharmacy specific monthly and quarterly quality assurance report template • Under the direct supervision, document results of deviation and compliant investigations, causal analysis, corrective actions and prevention actions • Support internal and external audits of pharmacy cleanrooms across the healthsystem • Maintain quality records, including equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, and clean room certification • Oversight of the quarantine program for batched sterile compounds • Participate in pharmacy leadership staff meetings • Precept pharmacy students, PGY1 residents, and PGY2 health-system pharmacy administration residents