Regulatory affairs Jobs in St Petersburg, FL

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 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 <797> 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. Manages location 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 <797> and <800> 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. Functions as back up to the Pharmacy Technology Specialist, Pharmacy Controlled Substance Specialist, and Pharmacy Buyer at some sites when required. • Attend department meetings, facility in-services, and special corporate events and/or meetings. • Assumes the responsibility for professional growth and development. 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 requiredEvaluates 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 <797> 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. Manages location 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 <797> and <800> 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. Functions as back up to the Pharmacy Technology Specialist, Pharmacy Controlled Substance Specialist, and Pharmacy Buyer at some sites when required. • Attend department meetings, facility in-services, and special corporate events and/or meetings. • Assumes the responsibility for professional growth and development. 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