Pharmacy Technician Specialist - USP 800 Compliance
Nationwide Children's HospitalAbout the role
Overview:
- This position is 50% staffing in our Hem/Onc pharmacy and 50% USP 800 (or hazardous drug handling) compliance.
- Primarily Schedule - Monday to Friday - 8 hours shift - Between 6 AM and 5 PM
- Weekend and Holiday Rotations Required
Job Description Summary:
The Pharmacy Compliance Technician provides compliance and quality improvement support to the pharmacy enterprise. This role will work in conjunction with Pharmacy Administration and Education teams to plan, schedule and conduct routine audits and administrative tasks to support the quality management program and to assure regulatory and compliance with applicable regulations, policies, procedures and expectations. This includes compliance assessments with USP 795, 797, 800, DEA, and FDA regulations, CMS guidance, and State Board of Pharmacy requirements. This position will lead a variety of quality improvement and process improvement initiatives as requested by and at the direction of Pharmacy Administration.
Job Description:
Essential Functions:
Understand requirements and regulations related to non-sterile compounding (USP795), sterile compounding (USP797), and hazardous compounding (USP800).
Maintain a current knowledge base of all applicable national and state regulations, including understanding and assessment of the State Board of Pharmacy requirements around storage, preparation, and dispensing of medications.
Assist Pharmacy Administration in developing annual and as needed education and remediation planning efforts to ensure compliance.
Assistance in develop and routine audits of staff processes, protocols, and standard operation procedures related to medication storage, preparation, and dispensing.
Conduct surveillance of various non-pharmacy areas related to compliance and adherence to expected pharmacy regulatory requirements as well as NCH and Department of Pharmacy policies and procedures.
Provide quality and process improvement support under guidance of Pharmacy Administration.
Assist with quality and process improvement training, as needed.
Complete surface, air, and other environmental testing and/or coordinate testing with external vendors.
Complete assigned/designated cleaning and compliance tasks as assigned.
Lead / conduct internal audits and vendor/product audits to ensure compliance.
Active engagement and awareness of list-serve, practice advancements, and legal/regulatory changes, including occasional seminar or conference attendance.
Act as liaison/ provide support during regulatory audits.
Review, register, and maintain required documents including, but not limited to, Batch Record Documents, Standard Operating Procedures (SOPs), and policies/procedures.
Education Requirement:
High school diploma or equivalent; Bachelor’s degree preferred.
Licensure Requirement:
Registered with the Ohio State Board of Pharmacy as a Certified Registered Technician.
Certifications:
Certification by examination as a pharmacy technician (CPhT, ExCPT).
Skills:
- Must demonstrate ongoing Inpatient Pharmacy Tech I competencies, knowledge, and skills minimally.
- Demonstrated leadership skills in pharmacy work environment.
- Excellent computer skills required: Microsoft Office Suite, SharePoint.
- Knowledge and expertise in the principles of medication and pharmacy regulatory requirements including USP, the State Board of Pharmacy, and other regulatory agencies are preferred.
Experience:
- At least 3 years of experience as pharmacy technician; prefer at least one year of experi
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