Pharmacist Compounding Compliance Coordinator
![]() | |
![]() United States, Massachusetts, Boston | |
![]() 75 Francis Street (Show on map) | |
![]() | |
Principal Duties and Responsibilities
1.Maintains and coordinates a comprehensive and standardized compounding quality assurance program for the department which facilitates the achievement of positive outcomes, is consistent with current accepted practice in pharmacy, and can be integrated with service programs in all compounding areas. 2.Ensures proper documentation and filing of all training and compounding environmental monitoring, room and hood certifications, calibrations, cleaning, and other documents related to regulatory compliance. 3.Works with compounding pharmacy management and staff to review and analyze findings to provide guidance to facilitate change and implement plans of correction, if applicable, through the established pharmacy compounding corrective action/preventative action (CAPA) program to ensure proper remediation and closure. 4.Serves as a subject matter expert to assist in identifying and mitigating ongoing risk through review of data and analytics, reviewing day-to-day deviations/excursions/concerns in the quality assurance plans to remediate in real-time, performing trend analysis to identify possible risk at local and MGB systems-level through a hierarchical escalation process. 5.Provides knowledge and support to the compounding areas, with compliance-centric process audits, root cause analysis, and quality assurance and performance improvement initiatives. 6.Oversee the work of the quality assurance coordinator and all environmental monitoring and continuous monitoring results, required compliance documentation, and CAPAs as applicable. Additional Duties Responsible for the optimization of drug therapy by identification, resolution, and prevention of drug related problems and improving therapeutic outcomes. Provides patient care according to the laws and regulations governing pharmacists and the practice of pharmacy by the appropriate state and federal agencies. May be responsible for prescribing medications under specific collaborative drug therapy management agreements (CDTM). Works independently, and within the limits of established pharmacy/ambulatory care practice site's policies and procedures, as a member of the patient care team. May supervises support personnel during an assigned shift, operating within the limits of pharmacy policy and procedures, and the regulations of the Board of Registration Pharmacy. Does this position require Patient Care? No Essential Functions -Leadership - 20% a. Provide direction and guidance to pharmacist and ancillary support including technician staff in following policy and procedure, taking accountability and ownership of job responsibilities, and promoting professional behavior and attitudes. Give feedback to the pharmacy managers/practice managers/medical directors for performance appraisal of other Pharmacy employees. Participates in resolving personnel management issues, when requested by the management staff. -2. Direct and Indirect Patient Care Services - 50% a. Attend and participate in departmental staff meetings, M&M rounds, staff development, journal club review, in-services, and case studies for afternoon pharmacist meetings and continuing education activities. b. Member of departmental quality improvement committees, programs, and student/resident presentations. c. Conduct continuing education programs and conferences to keep current with developments in the profession. d. Maintain pharmaceutical care expertise through membership and participation in professional organizations, continuing education, and contributing to peer-reviewed literature. -3. Quality and Safety - 10% a. Maintain expertise in the departmental policies and procedures. b. Follow all policies, procedures, laws, and regulations set forth by the Board of Pharmacy and all other applicable regulatory agencies. c. Ensure compliance with target drug programs, formulary management, medication management initiatives, and adverse drug event monitoring programs. -4. Education, Training, and Professional Development - 10% a. Attend and participate in departmental and change of shift staff meetings, M&M rounds, staff development and continuing education activities. b. Participate in departmental quality improvement committees, programs, and student/resident presentations. -5. Use of Technology and Automation - 10% a. Utilize area-specific technology, including, but not limited to, robotics, automation, software, equipment, and information systems. b. Troubleshoot and mitigate short-term issues related to the area specific technology. Education Must demonstrate a high level of expertise in United Stated Pharmacopeia (USP) chapters <797>, <795>, <85>, <71> and other areas of quality that relates to the practice of pharmacy. Expertise in compliance standards and regulations promulgated by the relevant agencies: DPH, BORP, TJC, CMS, and the FDA Understanding of Lean Principles, Project Management, and Process Improvement Must be able to read, interpret, and report microbiological test results, environmental monitoring test results, end-product test results, and test results from sterile compounding assessments. Must be able to perform as a leader providing direction and guidance to less experienced personnel with regards to quality assurance and all USP regulations. Must have the ability to work independently, evaluate situations, and act appropriately. Must possess a high level of interpersonal and communication skills to interact courteously and effectively with co-workers, clinicians, other hospital personnel and other outside vendors. Board Certified Sterile Compounding Pharmacist (BCSCP) certification is preferred. Physical Requirements
The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. |