Cellular Therapy & Transplant Quality Specialist

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Brief Overview

The Cellular Therapy & Transplant Section (CTTS) is a multidisciplinary team that provides outstanding clinical care, cutting edge research, and produces high quality outcomes. CTTS consists of two programs The Blood and
Marrow Transplantation (BMT) program and the Cell Therapy program (CIP). CTTS treats a variety of diseases utilizing hematopoietic progenitor cells (HPC), genetically modified HPC and immune effector cells (IEC).

Diseases treated include certain types of cancer, disorders of the blood and immune system as well as a wide variety of other rare disorders and syndromes. CTTS operations must comply with the Foundation for theAccreditation of Cellular Therapy (FACT) which requires a robust and active Quality Management Program (QMP) to comply with all required regulations and accreditation standards.

The CTTS Quality Specialist role works under the oversight of Senior CTTS Leadership which includes the Section Chief, Medical and Operations Directors who oversee the quality improvement initiatives and overall implementation of the QMP. The overall management of the QMP is the responsibility of the CTTS Quality Manager. The CTTS QMP includes all key components of CTTS. This includes clinical, collection and processing.

The QMP goal is to set quality standards, identify system problems, develop corrective actions, and formulate recommendations through ongoing audits, quality control, quality improvement initiatives and education. The Quality Specialist's primary responsibility is to perform routine Quality Assurance (QA) and Document Control functions as determined by the CTTS senior leaders and Quality Manager.

This team member plays a vital role within the section by working to assure compliance with FACT and Good Tissue Practices (GTPs). All employees are responsible for compliance with written policies and procedures and for correctness, truthfulness, timeliness, legibility, integrity, and accuracy when recording data and observations in compliance with CHOP policies and accreditation requirements.

JOB FUNCTIONS

Essential Functions

* Knowledge of Quality Assurance & Quality Improvement processes

* Knowledge of CTTS policies and procedures

* Performs routine QA functions including but not limited to: * Drafts and reviews policies and procedures

* Informs & educates staff of new and revised policies and procedures * Assist in planning, tracking, processing and investigating deviations

* Initiates incident reports and planned deviations.

Essential Functions

* Plans and participates in corrective and preventative actions and change implementation

* Performs chart reviews and audits per the quality management plan and as assigned * Maintain systems, databases, procedures, and websites for records and reporting.

* Collaborates with internal and external stakeholders to CTTS

* Plans, participates and engages in relevant department meetings * Meets project deadlines

* Proficient in various applications and tools including but not limited to Microsoft Office

QUALIFICATIONS

Education Level:

Bachelor's Degree in biological science, medical technology, or other health related field.

Required Work Experience

At least three (3) years in quality improvement, and quality management education Required

Formal training in lean six sigma, with experience in lean six sigma methodologies, knowledge of and/or experience in data tracking, trending and statistical process control analysis Preferred

Licenses, Certifications, and Registrations

Six Sigma Green Belt (CSSGB) American Society for Quality (ASQ) upon hire Preferred

Registered Nurse (Pennsylvania) PA state licensing dept upon hire Preferred

Licensed Practical Nurse (LPN) (Pennsylvania) PA state licensing dept upon hire Preferred

Knowledge, Skills and Abilities Skills Required

Must be a flexible thinker, with an ability to quickly adapt to a rapidly changing environment Required

Demonstrated ability to prioritize work, strong organizational and documentation skills and initiative to improve processes Required

Team-oriented, self-starting individual with excellent communication skills. Required Works well under stress & meets deadlines Required

Skills and knowledge of federal regulations pertaining to clinical research, International Council of Harmonization (ICH) and Good Clinical Practices (GCP) Preferred Experience working with quality improvement methods and tools Required Knowledge of QA procedures and policies Required

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.

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SALARY RANGE:

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.