Pharmacy Quality Compliance Coordinator (Full-Time/Hybrid, 8-Hour Day Shifts)

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Day - 08 Hour (United States of America)

This is a Stanford Health Care job.

A Brief Overview
Ensures organizational compliance with federal/state regulations and accreditation requirements (FDA, CDPH, BOP, TJC, etc.) for medication management. Develops audit templates and coordinates/performs required monthly compliance monitoring of enterprise-wide medication storage areas, including investigational drugs and sterile compounding areas. Reviews, analyzes, and trends data to identify gaps and participates/leads process improvement activities.

Locations
Stanford Health Care

What you will do

• Designs, performs, and revises monthly compliance inspections.
• Reviews and analyzes inspection results and medication error data to identify trends and opportunities for process improvement.
• Participates in/leads identified process improvement opportunities as appropriate.
• Develops and contributes key performance indicator (KPI) data to the Pharmacy Quality Dashboard. Assist in maintaining dashboard.
• Supports regulatory surveys and study monitor visits (IDS) as applicable.
• Communicates and educates operational staff (e.g. front-line staff, clinic managers, nurse managers, etc.) on medication-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, sample medications, investigational studies, and related topics.
• Responds to inquiries related to compliance issues. Researches applicable regulations/standards and provides appropriate guidance. Develops repository of inquiries and responses for future reference.
• Works collaboratively with other Pharmacy Quality Team members to assist with other duties as needed.
• Research activities (e.g. abstracts, posters, publications) are encouraged.
• Attends Pharmacy Management meetings to communicate overlapping issues, e.g., Patients'-Own-Meds, Multi-Dose Vial compliance, flu vaccine supplies, investigational studies, automated dispensing cabinet (ADC) installations , etc.
• Communicates and educates Clinic Administration, Clinic Managers and clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs, sample medications, investigational studies, and other related medications.
• Coordinates work of pharmacist assisting with monthly inspections.
• Coordinates, supervises, performs, and electronically reports monthly inspections of all outpatient drug storage areas on-site and remote sites.
• Responds to manager inquiries related to compliance issues.

Education Qualifications

• Other Other PharmD from an accredited college/university.dited college/university.

Experience Qualifications

• Five (5) years of progressively responsible and directly related work experience.experience.

Required Knowledge, Skills and Abilities

• Ability to effectively prioritize work and meet deadlines in a fast- paced environment.
• Ability to plan, organize, prioritize, work independently, and meet deadlines.
• Ability to learn quickly and adapt nimbly to change.
• Ability to interpret regulatory standards and application to SHC practices.
• Demonstrated ability to significantly collaborate both intra- and interdepartmentally.
• Proficiency with data management, data analysis, project management, presentation, and organizational softwares (e.g. MS Word, MS Excel, MS Visio, MS Outlook, MS PowerPoint).
• Strong critical thinking and problem solving skills
• Knowledge of methods and procedures involved in proper handling and storing of pharmaceuticals, including investigational drugs supplies.
• Knowledge of regulations, methods, and procedures involved in preparation of non-sterile and sterile pharmaceuticals.
• Knowledge of change management and process improvement methodologies.
• Knowledge of prescription and non-prescription drugs and drug products and their indications, efficacy, dosage, mechanisms of action; fate and disposition (if known), major contraindications and potential side effects.
• Knowledge of influence of patient's age, sex, concomitant disease states, concurrent drug therapy, foods and diagnostic procedures on drug activity and disposition.
• Knowledge of Medical terminology and abbreviations; pharmacology and pharmacological nomenclature; medical therapeutics, pharmacokinetics, and disease states.
• Knowledge of methods and proc