Compounding Quality Assurance Specialist

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The Compounding Quality Assurance Specialist reports to the Assistant Director Pharmacy Compounding Services and is responsible supporting the pharmacies in the Johns Hopkins Health System with compounding compliance. This individual will positively affect patient care by participating in quality assurance, regulatory compliance, facilities/equipment maintenance, staff education/training, and applicable documentation.

Shift:
Full Time (40 hours)- This position is approved for some remote work.
Day Shift 8:00am - 4:30pm
Weekends may be required

Education:

• Requires a high school diploma or equivalent
• College degree preferred

Licensure/Certification:

• Current Maryland Board of Pharmacy Registration required.
• PTCB pharmacy technician certification required.
• Advanced certifications such as PTCB Compounded Sterile Preparation (CSPT) and/or ASHP Compounded Sterile Preparations Certificate preferred.
• JHH Intravenous (IV) Certification (includes aseptic technique and hazardous substance handling) within 90 days of hire.

Required Work Experience:

• Minimum 2 years of experience in the preparation of nonsterile and sterile compounding
• Hospital pharmacy, pharmacy infusion service, or 503B experience preferred.
• Advance training in compounding, microbiology, or laboratory experience desired.

Knowledge, Skills and Abilities:

• Comprehensive understanding of inpatient and ambulatory pharmacy operations, procedures, and equipment
• Knowledge of pharmacy terminology, metric system weights/measures, and compounding practices
• Thorough understanding of hazardous drug handling requirements
• Strong attention to detail
• Ability to independently complete and lead projects
• Understanding and application of aseptic technique, and extensive knowledge in compounding standards USP <795>, <797> and <800> preferred
• Analytical ability to recognize and solve problems in assigned areas
• Excellent prioritization, customer service skills and the ability to exercise initiative and judgment
• Interpersonal skills necessary to obtain, verify and exchange information with third party vendors, supply chain, pharmacy, facilities, environmental care services, and hospital epidemiology and infection control
• Proficient written and verbal communication with proven ability to work effectively with others
• Aptitude to serve as a role model for compounding personnel
• Methodical ability to maintain records
• Proficiency to type a minimum of 40 words per minute
• Proficient computer skills with demonstrated analytical experience and data retrieval is preferred
• Ability to utilize presentation programs, word processing, spreadsheet software, and/or graphics applications is highly desired

The Compounding Quality Assurance Specialist will:

• Conduct routine pharmacy audits and employee obeservations for JHH/JHHS to evaluate aseptic technique and compliance with procedures
• Actively participate in the JHHS USP Committee, contributing to projects and supporting follow up
• Develop and deliver JHH/JHHS training as needed to support regulatory and operational standards
• Support sites with compounding or USP-related questions
• Administer aseptic competencies/media fill test for select employees
• Schedule and coordinate JHH equipment maintenance annually
• Provide support to the cleanroom certifier as needed for JHH monthly sampling and certifications
• Manage centralized coordination and purchasing of media fill supplies to support JHH employee aseptic competency assessments
• Coordinate with vendors for JHH compounding needs, including scheduling of hazardous drug wipe sampling
• Maintain and update JHH spreadsheet of microbiology results of monthy sampling in compounding areas

Salary Range: Minimum $23.00/hour - Maximum $37.97/hour. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility.

In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority.

JHM prioritizes the health and well-being of every employee. Come be healthy at Hopkins!

Diversity and Inclusion are Johns Hopkins Medicine Core Values. We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences, where all employees feel valued, contribute to our mission of serving the community, and engage in equitable healthcare delivery and workforce practices.

Johns Hopkins Health System and its affiliates are drug-free workplace employers.