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Apheresis Quality Specialist

Company: Yale-New Haven Health
Location: New Haven
Posted on: June 9, 2021

Job Description:

Overview

This position is a member of the Stem Cell Transplant Program with accountability for programmatic quality oversight

as directed, inclusive of the Apheresis unit, to ensure compliance with all applicable regulatory agencies (FDA,

FACT, AABB, etc.). The incumbent is responsible for coordinating all quality activities in Apheresis to support the

Adult and Pediatric Hematopoietic Stem Cell Transplant and Immune Effector Cell Therapy Programs, as well

as all clinical trials involving investigational cell therapy products. Responsible for all quality aspects in cellular

products manufacturing (collection, labeling, storage, transporting, release/dispensing) to support the Stem

Cell Transplant Program and clinical trials (INDs) conducted at YNHH. It also includes analysis of quality and

performance improvement including coordination and collection of data, analysis and trending of required

regulatory indicators (internal and external), process measures and clinical outcomes measures. This

position interacts closely with the unit manager and staff in these areas to assure compliance with the

Foundation for the Accreditation of Cellular Therapy (FACT) standards and other quality measures identified by

program leadership. Education to promote regulatory readiness and ongoing accreditation compliance.

EEO/AA/Disability/Veteran.

Responsibilities

  1. Develops, revises and maintains the quality management plan for the Apheresis unit, integrating with

the quality management plans for the other Stem Cell Transplant program components .

  1. Reviews and is knowledgeable about all applicable regulations of the FDA, FACT, AABB, CAP, CLIA,

TJC, State of Connecticut and other relevant agencies. Monitors all new regulations and ensures that

processes and procedures comply with requirements.

  1. Ensures that the Apheresis unit is prepared for regulatory site visits and other external audits. Maintains

associated applications, checklists, and other documents related to regulatory/ accreditation compliance.

  1. Serves as a resource and consultant for quality activities to the clinical program and marrow collections staff

as needed.

  1. Facilitates the coordination of multidisciplinary efforts in regard to regulatory readiness. Provides leadership

in meeting goals and objectives.

  1. Prepares periodic reports regarding quality activities, and presents as needed on the status of the quality

management system.

  1. Conducts audits to ensure the quality management system is operating effectively; analyzes collected

data , and coordinates multidisciplinary corrective action plans and quality improvement activities.

  1. Reviews Event and Variance/Deviation reports from Apheresis; makes recommendations for corrective and

preventive actions and tracks and trends events. Reports Biological Product Deviations to FDA as required.

  1. Maintains the Document Control system for Apheresis.

  2. Reviews all SOPs, policies, change controls, corrective and preventative action plans, and

engraftment/outcome data.

  1. Reviews and approves training materials and competency assessments to ensure that all personnel have

been trained and are competent in any new or revised procedure that apply to their duties and training /

competency is documented.

  1. Qualifies and approves suppliers of critical equipment, supplies and services.

  2. Creates, reviews and implements validation plans to ensure compliance with all applicable regulations.

  3. In conjunction with Medical Director and Facility Director communicates with study principal

investigators, IRB & FDA.

  1. As necessary, facilitates and coordinates projects to improve processes in Apheresis. Interacts with

directors, managers, and staff in relation to projects.

  1. Keeps abreast of recent developments in the Apheresis and Cellular Therapy field.

  2. Performs other job duties as required

Qualifications

EDUCATION (number of years and type required to perform the position duties):

Bachelor's degree in a healthcare specialty (e.g., Nursing, Allied Health) required

EXPERIENCE (number of years and type required to meet an acceptable level of performance):

One to three years experience in a healthcare specialty required; experience in apheresis, cell therapy/ stem cell

transplantation, and/or regulatory compliance/quality assurance preferred.

SPECIAL SKILLS:

Excellent organizational, verbal and written communication skills, as well as presentation skills required. Must be

proficient in the use of Microsoft Word , Powerpoint and Excel.

ACCOUNTABILITY (how this position is held accountable for such as goals achievement, budget adherence, or

other areas of accountability):

Direct report to Quality Manager, Stem Cell Transplant Program

COMPLEXITY (describe planning, problem solving, decision making, creative activity, or other special factors

inherent in the responsibilities of this position):

In personal and job-related decisions and actions, consistently demonstrates the values of integrity (doing the right

thing), patient-centered (putting patients and families first), respect (valuing all people and embracing all differences),

accountability (being responsible and taking action), and compassion (being empathetic).

LICENSURE/CERTIFICATION:

RN, Clinical Laboratory Specialist, or Medical Technologist (ASCP) preferred.

Additional Information

YNHHS Requisition ID

17173

Keywords: Yale-New Haven Health, New Haven , Apheresis Quality Specialist, Other , New Haven, Connecticut

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