Pharmacy Regulatory Compliance Specialist at Lake Mary Hospital

Orlando Health • Lake Mary, FL

3d • Onsite

About The Position

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.

Requirements

• 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
• Experience in hospital pharmacy or regulatory compliance
• Knowledge of pharmacy regulations and accreditation standards
• Strong attention to detail and organizational skills

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.
• 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.
• 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.
• Generate and manage Event Reports related to medication errors or misadventures.
• Collect and analyze data to support safety and operational improvement initiatives.
• 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.
• 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.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees