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Pharmaceutical Compliance Officer

2 months 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 Pharmaceutical Compliance Officer is tasked with ensuring that both sterile and non-sterile compounding processes (including hazardous and non-hazardous) adhere to established policies and regulatory standards, encompassing state, federal, and accreditation guidelines.

This role involves overseeing training, competency assessments, and documentation for Pharmacy and Environmental Services team members, while also ensuring optimal environmental conditions in compounding areas.

The Pharmaceutical Compliance Officer will act as a Designated Person for USP , , and standards.

Qualifications:
Bachelor's Degree in Pharmacy
Experience should be from an inpatient hospital pharmacy or infusion center pharmacy, with a strong background in sterile compounding.
4-5 years of clinical pharmacy experience
Must demonstrate proficiency in the fundamental principles of sterile compounding.
Excellent interpersonal skills are essential.
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 workflows to ensure compliance with all relevant policies and standards pertaining to sterile and non-sterile compounding (hazardous and non-hazardous).

Continuously evaluates and analyzes compounding workflows and processes, questioning their effectiveness and proposing innovative solutions to enhance quality, safety, and efficiency.

Ensures the competency of all personnel involved in sterile and non-sterile compounding. 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 required 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 collection for primary and secondary engineering controls and the physical environment, as mandated by state and federal regulations.

Ensures proper documentation is completed. 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.

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

Exhibits expert knowledge of USP , , and regulations and applies them in challenging, high-pressure situations.

Capable of interpreting and clarifying ambiguous rules and regulations. Guides others in understanding these regulations and trains them accordingly. Participates in scheduled and unscheduled Board of Pharmacy Inspections 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 sterile and non-sterile compounding outcomes as outlined in the Clinical Pharmacist job description.

Rotates through on-call duties to advise local Designated Persons and site pharmacy leadership in 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