CLINICAL PHARMACIST COMPLIANCE SPECIALIST

Job Overview: Under the direction of the Pharmacy Compounding Coordinators and Director of Pharmacy Operations, the Clinical Pharmacist Compliance Specialist is responsible for assuring that sterile and non-sterile compounding (hazardous and non-hazardous) is performed in accordance with established policies and procedures, including state, federal, and accreditation statutes/standards. This individual will be responsible for Pharmacy and EVS team member training, competencies, and documentation and ensuring appropriate environmental control of the compounding areas. The Clinical Pharmacist Compliance Specialist will serve as a Designated Person for USP , , and . Job Requirements: Bachelor's Degree, Pharmacy Experience must be from an inpatient hospital pharmacy or infusion center pharmacy. Sterile compounding experience is required. 4-5 years experience Clinical, Pharmacy Must be able to demonstrate mastery over the fundamental principles of sterile compounding. Must of excellent interpersonal skills. Compounded Sterile Preparations Pharmacy Specialty Certification (BCSCP). Must receive certification within (2) two years of hire and maintain certification while in position. Job Responsibilities: Coordinates, monitors, and audits compounding workflows to ensure compliance with all policies and standards of work related to sterile and non-sterile compounding (hazardous and non-hazardous). Continuously analyzes and evaluates compounding workflows and processes by questioning their value to the process and contributing creative solutions to enhance quality, safety, and efficiency. Ensures the competency of all individuals involved in sterile and non-sterile compounding. Educates and trains team members that are new to non-sterile and/or sterile compounding. Provides topics for site daily huddles, memos, and team meettings as needed and team members involved in compounding at the required intervals. Responsible for the proper monitoring of the collected samples and documentation of results. Escalates testing failures to the Site Pharmacy Leadership and Pharmacy Compliance Coordinators. Collaborates with site leadership to create Corrective and Preventive Action Plans for identified areas of non-compliance. Communicates action plans to Compounding Compliance Coordinators. Oversees the recertification and environmental sampling collection for primary and secondary engineering controls and physical environment, as required by state and federal regulations. Completes proper documentation. Responsible for the proper monitoring of the collected samples and documentation of results. Escalates testing failures to the Site Pharmacy Leadership and Pharmacy Compliance Coordinators. Collaborates with site leadership to create Corrective and Preventive Action Plans for identified areas of non-compliance. Communicates action plans to Compounding Compliance Coordinators. Participates and provides a pharmacist's expertise in the creation, review, and revision of compounding Policies, Procedures, Standards of Work, Master Formulation Records, and Hazardous Drug Assessments. Demonstrates expert knowledge of USP , , and rules and regulations and applies them in difficult, stressful, and complex situations. Able to interpret and explain rules and regulations that are ambiguous or unclear. Directs others in interpreting rules and regulations on the job and trains others in them. Participates in planned/unplanned Board of Pharmacy Inspections and Joint Commission Surveys, as applicable. Maintains compounding skills and knowledge through staffing an average of 4 shifts per month in the Inpatient Pharmacy and/or Infusion Center Pharmacy, as required and applicable. Responsible for all sterile compounding and non-sterile job outcomes in the Clinical Pharmacist job description. Rotates through on-call to advise local DPs and site pharmacy leadership in handling excursions

Created: 2024-11-02