Pharmacy Regulatory Compliance Specialist

Position Summary

Site: FMCOH Wiregrass Ranch Hospital

Location: Wesley Chapel, Florida
Position: Pharmacy Regulatory Compliance Specialist

Department: Pharmacy

Elevating Healthcare in Wesley Chapel and West Florida, Florida Medical Clinic Orlando Health Wiregrass Ranch Hospital is poised to revolutionize healthcare in Wesley Chapel and the broader West Florida region. This five-story, state-of-the-art multi-specialty hospital spans 380,000 square feet, purpose-built to serve one of Florida's fastest-growing communities with exceptional, outcomes-focused care.

Designed for Excellence:

• Opening with 102 beds, expandable to 300 beds at full build-out
• 9 advanced operating rooms, including a hybrid OR with real-time imaging capabilities
• Comprehensive services in cardiology, neurology, oncology, surgery, and more

From life-saving procedures to advanced diagnostics, this facility is engineered to meet the evolving needs of our community with precision and compassion.

Job SummaryEnsures 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

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.
  • 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 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.
• 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 required.

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