Pharmacy Regulatory Compliance Specialist - Pharmacy - Bayfront Hospital
Orlando Health
Position Summary Ensures compliance with required pharmacy inspection and documentation of emergency code carts / boxes and enter the results into Performance Improvement database as identified. Oversee and ensure compliance with the Agency for Health Care Administration (AHCA), OSHA, CMS regulations, The Joint Commission, Board of Pharmacy and Orlando Health environment of care requirements. Adheres to the United States Pharmacopeia (USP) compliance standards. Responsibilities Evaluates and oversees compliance in designated location adhering to (USP) 795, 797 and 800 regulations. Coordinates semiannual education and competency assessments for all pharmacy personnel involved in the medication use processes including compounding, medication handling (including hazardous), and appropriate clean up and disposal. Responsible for the environment and cleaning of room IV. Maintains and evaluates the ISO room classifications of the sterile compounding rooms including monthly surface sampling. Coordinates semi-annual testing of the clean room with the room certifier. Ensures remediation of the sterile compounding area rooms and documents as needed. Designated Site Representative for USP Compliance. Assists with the training of team and certification of the IV room. Maintains ongoing continuing education as designated by policy, standards, and regulations. Serves as the designated person by site per the requirements of USP 797 for the I.V room. Investigates each event, entering and analyzing data from CQI sheets. Identifies and implements action steps to prevent future errors. Facilitates and records CQI staff meetings. Manages location specific Pharmacy Continuous Quality Improvement (CQI) program. Prepares and presents compliance data during inspections by regulatory bodies (e.g., Board of Pharmacy, Joint Commission, EPA). Monitors and ensures adherence to USP and standards in sterile compounding areas. Generates and manages event reports related to medication errors or misadventures. Collects and analyzes data to support safety and operational improvement initiatives. Evaluates compliance with Joint Commission National Patient Safety Goals. Collaborates with staff and leadership to implement medication-related safety goals under the guidance of regulatory personnel and pharmacy management. Collaborates with Pharmacy Technology Specialist, Buyer, and Controlled Substance Specialist to enhance dispensing safety and integrity. Coordinates with pharmacy leadership to ensure staff participation in medication safety training and documents attendance. Maintains punctual and regular attendance in accordance with Orlando Health policies and applicable laws (ADA, FMLA). Ensures compliance with all Orlando Health policies and procedures. Serves on relevant committees and task forces related to regulatory compliance and medication safety. Develops and delivers site‑specific in‑services for pharmacy and hospital staff. Evaluates and documents Pharmacy Technician Annual Clinical Reviews. Functions as backup to the Pharmacy Technology Specialist, Pharmacy Controlled Substance Specialist, and Pharmacy Buyer at some sites when required. Attends department meetings, facility in‑services, and special corporate events and/or meetings. Assumes responsibility for professional growth and development. Qualifications High school diploma or equivalent required. Required registered as a pharmacy technician with the State Board of Pharmacy, renewed every two years. Two (2) years of pharmacy experience required. #J-18808-Ljbffr
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