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Compounding Compliance Manager - Pharmacy

Palo Alto, CA, USA | Stanford Health Care hospital

  • Industry:
    Healthcare - Hospitals
  • Position Type:
    Full-Time
  • Functions:
    Biotech/R&D/Science
  • Experience:
    3-5 years
Job Description:
76 people have viewed this job

The Compounding Compliance Manager will be responsible for ensuring the regulatory (Board of Pharmacy, USP 795/797/800) compliance of all sterile and nonsterile compounding programs. This role is responsible for developing and updating policies and standard operating procedures, designing training programs, and ensuring standardized compounding operations across pharmacies enterprise-wide by providing guidance to Pharmacists-in-Charge and IV Room Supervisors. This role also designs and monitors quality compounding metrics, has oversight of the master formula development process, helps prepare sites for and participates in regulatory inspections, and leads monthly sterile compounding meetings.The Compounding Compliance Manager also performs risk assessments, root cause analyses, and other process/quality improvement activities as needed.


Essential Functions


The essential functions listed are typical examples of work performed by positions in this job classification, and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned


Employees must abide by all Joint Commission requirements including, but not limited to, sensitivity to cultural diversity, patient care, patients’ rights and ethical treatment, safety and security of physical environments, emergency management, teamwork, respect for others, participation in ongoing education and training, communication and adherence to safety and quality programs, sustaining compliance with National Patient Safety Goals, and licensure and health screenings. 


Develop and maintain compounding policies, procedures, and master formulas


Perform site visits and routine audits of compounding practices; prepare for and participate in regulatory surveys


Provide compounding guidance to PICs, IV room supervisors and assist in process improvement/quality improvement activities


Lead compounding meetings and provide general staff education/awareness


Equal Opportunity Employer Stanford Health Care (SHC) strongly values diversity and is committed to equal opportunity and non-discrimination in all of its policies and practices, including the area of employment. Accordingly, SHC does not discriminate against any person on the basis of race, color, sex, sexual orientation or gender identity and/or expression, religion, age, national or ethnic origin, political beliefs, marital status, medical condition, genetic information, veteran status, or disability, or the perception of any of the above. People of all genders, members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply. Qualified applicants with criminal convictions will be considered after an individualized assessment of the conviction and the job requirements. 


Job Qualifications:


Minimum Qualifications


Education: Graduate of an accredited College of Pharmacy with PharmD 


Experience: Three (3) years of Sterile Compounding leadership or compounding quality assurance experience 


License/Certifications:


· Registered Pharmacist by the California State Board of Pharmacy


· Basic Life Support by American Heart Association


· ASHP Sterile Compounding Certification OR Board Certified Sterile Compounding Pharmacist by ASHP or BPS


Knowledge, Skills, and Abilities


These are the observable and measurable attributes and skills required to perform successfully the essential functions of the job and are generally demonstrated through qualifying experience, education, or licensure/certification. 


Knowledge of CA Board of Pharmacy Compounding requirements, USP 795/797/800, Joint Commission Medication Management Standards


Ability to critically analyze data/evaluate literature and draw appropriate conclusions


Ability to communicate effectively, both orally and in writing


Ability to think critically to interpret regulatory language


Ability to perform drug information queries


Ability to lead groups and meetings


Ability to multi-task


Skilled in problem solving


Skilled in process improvement activities


Skilled in reading certification reports


Skilled in trouble shooting out of range environmental monitoring


Skilled in answering surveyor/regulatory questions


Skilled in developing a peer network


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