What are the responsibilities and job description for the Quality and Compliance Specialist, Kraft Family Blood Donor Center, BWH position at Mass General Brigham?
The Quality and Compliance Officer for the Kraft Family Blood Donor Center is responsible for planning, coordinating, and monitoring that the daily work activities and operation of the Blood Donor Center, apheresis area, and blood mobile meet or exceed standards set by the FDA, TJC, FACT and AABB. The officer reports to and seeks guidance from the Nursing Director, and Medical Director of the Joint Program in Transfusion Medicine. (JPTM). Collaboration with the Blood Bank Compliance staff, Operations Director, Technical Director and MGB Path Quality & Safety team.
PRINCIPAL DUTIES AND RESPONSIBILITIES: Indicate key areas of responsibility, major job duties, special projects, and key objectives for this position. These items should be evaluated throughout the year and included in the written annual evaluation.
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Reviews and manages donation & apheresis practice (SOP's) to maintain high standards of patient and donor care. Provides technical expertise, assistance, and supervision for the daily operation of the center.
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Reviews and is knowledgeable about all applicable regulations of the FDA, FACT, AABB, CAP, CLIA, TJC, State of Massachusetts and other relevant agencies. Monitors all new regulations and ensures that processes and procedures comply with requirements.
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Leads the development and implementation of Standard Operating Procedures (SOPs) in accordance with department policies and regulatory standards.
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Ensures that the center is prepared for regulatory site visits and other external audits including those conducted by study sponsors. Maintains associated applications, checklists, and other documents related to regulatory/ accreditation compliance.
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Reviews quality agreements from research sponsors along with the research team, commercial products, vendors, other partners for potential new protocols, monitors amendments or revisions to existing protocols for changes that impact the apheresis unit and coordinates the apheresis unit's readiness to participate in a new protocol.
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Serves as a resource and consultant for quality activities to the clinical oncology and apheresis programs as needed.
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Conducts audits to ensure the quality management system is operating effectively; collects required data for audits directly, when possible, analyzes collected data, and coordinates multidisciplinary corrective action plans and quality improvement activities, serving as a close liaison with the BTS.
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As necessary, facilitates and coordinates projects to improve processes in Apheresis. Interacts with directors, managers, and staff in relation to projects.
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Assists with the development, revision, and maintenance of the quality management plan for the apheresis center and blood donor center.
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Participates in the development, review, and implementation of training protocols, tools, and plans. Provides GMP training of new staff.
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Ensures completion of training documents and competencies.
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Serves as a resource and consultant for quality activities to the clinical oncology and apheresis programs as needed.
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Facilitates the coordination of multidisciplinary efforts regarding regulatory readiness. Provides leadership in meeting goals and objectives.
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Prepares periodic reports regarding quality activities and presents as needed on the status of the quality management system in the Donor and Apheresis Unit.
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Prepares and communicates donor center quality activities at appropriate committees and meetings as needed/directed.
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Responsible for implementation of a quality assurance program including review of records and documentation of corrective action. Works collaboratively with Blood Bank Compliance, Apheresis Research Quality & Compliance Specialist, MGB Quality & Safety team to assure and improve the quality of outcomes.
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Participates in the interview and selection process of hiring new staff.
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Coordinates the donor center preparation for regulatory reviews and site certifications.
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Participates in Occurrence management. This includes timely follow up and corrective actions.
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Promotes spirit of professionalism and excellence in performance to the staff. Keeps informed and up to date on developments in the field, encourages same in staff members. Promotes continuing education throughout the organization.
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Complies with all hospital safety requirements. Is knowledgeable about hospital policies concerning fire drills, OSHA regulations, hazardous waste management, and chemical hygiene plan.
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Reviews Protocols to ensure Leukapheresis collection language is appropriate and that the research consents meet department standard.
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Participates in software upgrades and implementation of new software that impacts workflow.
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Other duties as assigned.
WORKING CONDITIONS:
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Ambulatory/Procedural setting with occasional travel to location of the blood mobile.
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Busy, sometimes hectic work area, with frequent interruptions.
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Walking, sitting, standing, occasional lifting.
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Full-time Monday through Friday, remote work 2-3 days per week once onboarded. Onboarding is a significant process pending experience which could be over a time period of 18 months.
SUPERVISORY RESPONSIBILITY: List the number of FTEs supervised.
Collaborates with the Nurse Director to address performance issues of technical/nursing staff.
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Bachelor's degree in Medical Technology, Biology, Nursing, Lab Sciences, or healthcare quality management preferred.
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2-3 years' experience in apheresis, blood bank, quality & safety, BMT, hem/onc.
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Preferred comprehensive knowledge of FDA, NMDP, AABB, TJC, FACT, DPH and other regulatory requirements preferred.
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Must have excellent writing skills
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Ability to work well and learn new computer systems and become a resource for the donor center system.
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Education and or experience can substitute for requirements.
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
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Ability to analyze complex problems and take initiative
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Skill in writing procedures
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Computer literate - Microsoft office and learn new computer systems
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Ability to work well and coach staff
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Ability to manager fluctuating priorities
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Make decisions quickly and confidently. Function calmly and effectively in stressful situations.
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Excellent communication and writing skills. Skilled in teaching and training.
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Ability to work well with others and communicate effectively in a collaborative atmosphere
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Ability to deal fairly and consistently with all staff.
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Ability to handle confidential information appropriately in conjunction with HIPAA policy.
BWH is an Affirmative Action Employer. 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.
Mass General Brigham 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.
