Job Title

Position Summary Department: LMH Pharmacy Status: Full-Time Schedule: First Shift Monday through Friday Title: Pharmacy Regulaatory Compliance Specialist Orlando Health Lake Mary Hospital Orlando Health Lake Mary Hospital represents Orlando Health's continued commitment to the Seminole County community, which we have proudly served for 40 years. As a comprehensive acute care facility, the hospital offers a full scope of medical and surgical services, including cardiovascular, general surgery, orthopedics, and women's services with labor and delivery, alongside a future NICU. Opening with 124 beds, the 455,000 square foot hospital will be able to expand to up to 240 beds. State-of-the-art facilities include operating rooms, catheterization labs, interventional radiology, a vascular lab, an ICU and a full-service emergency department. For labor and delivery, the hospital features six private suites thoughtfully designed to make you feel at home while providing exceptional medical care. Each suite includes a hydrotherapy tub for laboring, shower, recliner, adjustable bed with a squat bar, wireless and waterproof heart rate monitors for mom and baby, a smart board that integrates patient and nurse information from Epic, WiFi, and televisions. These modern amenities ensure a comfortable and supportive environment for every patient. Labor and delivery services, and a future neonatal intensive care unit 6 state-of-the-art operating rooms 3 catheterization labs with a dedicated interventional radiology and vascular lab Comprehensive cardiovascular care 16 ICU Beds Observation unit Outpatient Scripts Pharmacy Top Reasons to Choose Orlando Health - Lake Mary Hospital: BEST Place to Work, 5 years in a row! As a new hospital, Orlando Health Lake Mary offers unique opportunities for career advancement, leadership roles, and professional development. Benefits Package that begins on day one (Full-Time & Part-Time only). Flexible Schedules Tuition Reimbursement up to $5,000 a year. Position Summary: The Pharmacy Regulatory Compliance Specialist supports pharmacy operations by ensuring compliance with federal, state, and accrediting body regulations. This role partners with pharmacy leadership to maintain survey readiness, support audits, and promote safe and compliant medication-use practices. Key Responsibilities Monitor compliance with Board of Pharmacy, CMS, Joint Commission, AHCA, and USP , , and standards Coordinate regulatory audits, inspections, and required documentation Identify, track, and assist with resolution of compliance findings Support policy review, staff education, and performance improvement initiatives Assist with ongoing survey readiness and regulatory reporting Responsibilities Essential Functions Evaluates and oversees compliance in designated location adhering to (USP) 795, 797 and 800 regulations. Coordinates the 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 the semi-annual testing of the clean room with the room certifier. Ensures the remediation of the sterile compounding area rooms and document 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. Pharmacy Continuous Quality Improvement (CQI) Program 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. Manageslocation specific Pharmacy Continuous Quality Improvement (CQI) program. Regulatory Compliance & Inspections Prepare and present compliance data during inspections by regulatory bodies (e.g., Board of Pharmacy, Joint Commission, EPA). Monitor and ensure adherence to USP and standards in sterile compounding areas. Safety Medication & Reporting Generate and manage Event Reports related to medication errors or misadventures. Collect and analyze data to support safety and operational improvement initiatives. Joint Commission Standards Evaluate compliance with Joint Commission National Patient Safety Goals. Collaborate with staff and leadership to implement medication-related safety goals under the guidance of regulatory personnel and pharmacy management. Interdepartmental Coordination Collaborate with Pharmacy Technology Specialist, Buyer, and Controlled Substance Specialist to enhance dispensing safety and integrity. Coordinate with pharmacy leadership to ensure staff participation in medication safety training and document attendance. Administrative Duties Maintain punctual and regular attendance in accordance with Orlando Health policies and applicable laws (ADA, FMLA). Ensure compliance with all Orlando Health policies and procedures. Serve on relevant committees and task forces related to regulatory compliance and medication safety. Develop and deliver site-specific in-services for pharmacy and hospital staff. Evaluate and document Pharmacy Technician Annual Clinical Reviews. Qualifications Education/Training High school diploma or equivalent required. Licensure/Certification Required registered as a pharmacy technician with the State Board of Pharmacy, renewed every two years. Experience Two (2) years of pharmacy experience required Experience in hospital pharmacy or regulatory compliance Knowledge of pharmacy regulations and accreditation standards Strong attention to detail and organizational skills Education/Training High school diploma or equivalent required. Licensure/Certification Required registered as a pharmacy technician with the State Board of Pharmacy, renewed every two years. Experience Two (2) years of pharmacy experience required Experience in hospital pharmacy or regulatory compliance Knowledge of pharmacy regulations and accreditation standards Strong attention to detail and organizational skills Essential Functions Evaluates and oversees compliance in designated location adhering to (USP) 795, 797 and 800 regulations. Coordinates the 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 the semi-annual testing of the clean room with the room certifier. Ensures the remediation of the sterile compounding area rooms and document 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. Pharmacy Continuous Quality Improvement (CQI) Program 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. Manageslocation specific Pharmacy Continuous Quality Improvement (CQI) program. Regulatory Compliance & Inspections Prepare and present compliance data during inspections by regulatory bodies (e.g., Board of Pharmacy, Joint Commission, EPA). Monitor and ensure adherence to USP and standards in sterile compounding areas. Safety Medication & Reporting Generate and manage Event Reports related to medication errors or misadventures. Collect and analyze data to support safety and operational improvement initiatives. Joint Commission Standards Evaluate compliance with Joint Commission National Patient Safety Goals. Collaborate with staff and leadership to implement medication-related safety goals under the guidance of regulatory personnel and pharmacy management. Interdepartmental Coordination Collaborate with Pharmacy Technology Specialist, Buyer, and Controlled Substance Specialist to enhance dispensing safety and integrity. Coordinate with pharmacy leadership to ensure staff participation in medication safety training and document attendance. Administrative Duties Maintain punctual and regular attendance in accordance with Orlando Health policies and applicable laws (ADA, FMLA). Ensure compliance with all Orlando Health policies and procedures. Serve on relevant committees and task forces related to regulatory compliance and medication safety. Develop and deliver site-specific in-services for pharmacy and hospital staff. Evaluate and document Pharmacy Technician Annual Clinical Reviews.