Pharmaceutical Compliance Specialist

1 week ago

Cincinnati, Ohio, United States TriHealth Full time

Job Description

Position Overview:


Under the guidance of the Pharmacy Compounding Coordinators and the Director of Pharmacy Operations, the Clinical Pharmacist Compliance Specialist is tasked with ensuring that both sterile and non-sterile compounding (including hazardous and non-hazardous materials) adheres to established protocols and regulations, including state, federal, and accreditation standards.

This role involves training and competency assessments for Pharmacy and Environmental Services team members, along with maintaining appropriate environmental controls in compounding areas.

The Clinical Pharmacist Compliance Specialist will act as a Designated Person for USP , , and .

Qualifications:
Bachelor's Degree in Pharmacy
Experience should be in an inpatient hospital pharmacy or infusion center pharmacy, with a requirement for sterile compounding experience.
4-5 years of clinical pharmacy experience
Proficiency in the fundamental principles of sterile compounding is essential.
Excellent interpersonal skills are a must.
Certification in Compounded Sterile Preparations Pharmacy Specialty (BCSCP) is required within two years of hire and must be maintained throughout employment.

Key Responsibilities:


Oversees, monitors, and audits compounding processes to ensure compliance with all relevant policies and standards concerning sterile and non-sterile compounding (hazardous and non-hazardous).

Continuously assesses and improves compounding workflows and processes by evaluating their effectiveness and proposing innovative solutions to enhance quality, safety, and efficiency.

Ensures that all personnel involved in sterile and non-sterile compounding are competent. Provides education and training for new team members in both non-sterile and sterile compounding practices. Supplies topics for daily huddles, memos, and team meetings as necessary.
Recertifies team members engaged in compounding at designated intervals. Responsible for the accurate monitoring of collected samples and documentation of results. Reports testing failures to Site Pharmacy Leadership and Pharmacy Compliance Coordinators. Collaborates with site leadership to develop Corrective and Preventive Action Plans for identified compliance issues. Communicates action plans to Compounding Compliance Coordinators.

Supervises the recertification and environmental sampling for primary and secondary engineering controls and the physical environment, as mandated by state and federal regulations.

Ensures proper documentation is completed. Responsible for monitoring collected samples and documenting results accurately. Reports testing failures to Site Pharmacy Leadership and Pharmacy Compliance Coordinators. Works with site leadership to create Corrective and Preventive Action Plans for compliance issues. Communicates these plans to Compounding Compliance Coordinators.

Participates in the creation, review, and revision of compounding Policies, Procedures, Standards of Work, Master Formulation Records, and Hazardous Drug Assessments, providing pharmacist expertise.

Exhibits expert knowledge of USP , , and regulations and applies this knowledge in complex and high-pressure situations.

Capable of interpreting and clarifying ambiguous rules and regulations. Guides others in understanding these regulations and trains them accordingly. Participates in planned and unplanned inspections by the Board of Pharmacy and Joint Commission Surveys, as applicable.

Maintains compounding skills and knowledge by staffing an average of four shifts per month in the Inpatient Pharmacy and/or Infusion Center Pharmacy, as required.

Responsible for all outcomes related to sterile and non-sterile compounding as outlined in the Clinical Pharmacist job description.

Rotates on-call duties to advise local Designated Persons and site pharmacy leadership on managing excursions, unsanitary conditions, and other complex issues related to sterile or non-sterile compounding.


Additional Information:
Certification in Compounded Sterile Preparations Pharmacy Specialty (BCSCP) is required within two years of hire and must be maintained throughout employment.
Potential exposure to hazardous and toxic substances.

Work Environment:
Climbing - Rarely
Concentration - Consistently
Continuous Learning - Consistently

Hearing:
Conversation - Consistently

Interpersonal Communication - Consistently
Kneeling - Rarely
Lifting

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