The Department of Pharmacy Services at the University of Michigan Health System is seeking a special individual who can provide guidance and direction in the continuous improvement of medication compounding and hazardous drug handling to ensure safe and high quality patient care outcomes! This individual will positively affect patient care by providing in-depth oversight, monitoring, and mentoring related to quality assurance activities, regulatory compliance, facilities design and maintenance, staff education and training, and documentation related to medication compounding. Pharmacists on the Compounding Compliance Team will participate in assignments that foster deep understanding and ownership in one of the assigned areas of personnel development/monitoring, facilities monitoring, and policy/procedure/ reference maintenance. The span of responsibilities will cover sterile (USP <797>), non-sterile (USP <795>), and hazardous drug handling (USP <800>) compliance oversight. The target salary range will be based on the qualifications and experience of the selected candidate.
As an integral member of the Pharmacy Department Management team, the Clinical Pharmacist Specialists for Medication Compounding Compliance will work closely with Pharmacy leadership and collaborators from Clinical Risk, Facilities, Environmental Services, Pharmacy, Nursing, Infection Prevention, Accreditation Services, and Safety and Quality Improvement. The selected individual will:
Regulatory compliance & oversight.
- Serve as a content expert of USP <795>, <797>, <800> standards and other standards referenced within the chapters related to nonsterile, sterile, and hazardous drug compounding, including requirements for operations and facilities/equipment maintenance.
- Understand and keep up to date with the laws, regulations, accreditation and certification standards, and advancements related to sterile compounding. Inform staff of key provisions, interpretations, and changes to those laws.
- Write and review current sterile compounding policies and procedures to ensure ongoing compliance.
- Ensure pharmacy licenses, hood certification records, and other regulatory documentation are maintained and available for inspection.
- Represent pharmacy during regulatory visits.
- Work with area managers and staff to identify opportunities for improvement to all compounding services, programs, and facilities.
- Develop systems to track compliance and detect opportunities for increased compliance with current compounding standards both inside and outside of the Department of Pharmacy.
- Conduct periodic and extensive audits and inspections of pharmacy compounding areas, quality assurance monitoring programs, and employees to assure compliance with regulatory requirements and departmental policies.
- Collect or monitor environmental, personnel monitoring, and hazardous drug wipe samples for the purpose of assessing the state of environmental conditions, cleaning techniques, and personnel competence and adherence to departmental policies.
- Evaluate and functionally supervise the incubation and assessment of media samples
- Development and review of compounding education and competency assessment programs for compounding staff.
- Ensure that adequate training and regular competency assessment programs are in place to comply with required sterile compounding programs.
- In conjunction with the Assistant Director of Research and Education, ensure employee orientation, education and training records are maintained and are accessible.
- Provide group and individual training on techniques and departmental procedures as needed.
- Maintain competency in sterile product preparation by periodically participating in pharmacy sterile compounding checking/production, including possible weekend and evening coverage as scheduled.
- Perform regular reviews of the professional and regulatory literature, network with individuals performing similar responsibilities at other institutions, and become involved with professional organizations and committees where regulatory compliance is discussed.
- Report compliance with compounding requirements and quality improvement initiatives to pharmacy and hospital leadership on a regular basis.
- Lead pharmacy based, management committees to review compounding standards and ensure standardized procedures are used across practice sites.
- Coordinate meetings, create agendas, and write minutes.
- Maintain lists, databases, and perform data analysis as needed.
- Communicate with pharmacy technicians, managers, and leadership.
- Doctor of Pharmacy degree or an equivalent combination of education and experience
- Completion of a pharmacy residency or an equivalent combination of education, training, and experience
- Eligible to be licensed to practice as a pharmacist in the State of Michigan, or eligible to become licensed within 60 days of employment start date.
- Excellent organizational, teamwork, interpersonal, time management, consensus-building, and written and verbal communication skills
- Prior experience with sterile and nonsterile compounding, regulatory management, policy writing, compliance auditing, and/or quality improvement initiatives
- Excellent communication skills (fluency in writing, reading and speaking English)
- Proficiency with MS Word, Excel, PowerPoint, and other software
- Ability to perform a variety of manual dexterity movements (i.e., aseptic manipulations, keyboard data entry)
- Prior experience with regulatory oversight, quality assurance, and sterile and nonsterile compounding, accreditation/inspection site visits
- Prior experience working in manufacturing processes
- Completion of a Health Systems Pharmacy Administration residency
- Experience in student and resident education
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
Successful deployment of this position will be represented by achieving compliance with regulatory requirements related to medication compounding.
Direct supervision is received from the Assistant Director for Pharmacy Analytics, Quality, Regulatory, and Safety.
Direct supervision is provided to pharmacists and technicians; functional supervision is provided to pharmacy students and residents.
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Although the Posting End Date may indicate otherwise, this job may be filled and closed anytime after a posting duration of seven calendar days.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.