Apheresis Quality & Regulatory Coordinator

Organization Description

As dedicated professionals, our nurses support an environment of opportunity for personal growth and professional development, teaching each other and our patients and families important aspects of care.

Employer Description

As one of the nation's premier pediatric health care systems, we've made a promise to do whatever it takes to prevent and treat even the most disabling childhood conditions.

It's a promise that extends beyond our nationally recognized clinical treatment to an entire integrated spectrum of research, advocacy, education, and prevention.

Equity, diversity, and inclusion guide our growth and strategy.

We are looking for individuals who are passionate about, and committed to, leading efforts to provide culturally relevant care, reducing health disparities, and helping build a diverse and inclusive environment.

All Nemours Associates are expected to ensure that these philosophies are embedded in their day-to-day work with colleagues, patients and families.

Nemours aspires to have its workforce and providers reflect the rich diversity of the communities we serve.

Candidates of diverse backgrounds, race and ethnicity, religion, age, gender, sexual orientation, and those committed to working with diverse populations and conversant in multicultural values are strongly encouraged to apply.

Please click here to review Nemours Anti-Racism Statement (nemours.org) .

Program Description

Established in 2022, our Apheresis and Cellular Therapy Collections Program has evolved into a multidisciplinary team comprising three physicians, one advanced nurse practitioner, a dedicated nursing director, and three specialized apheresis nurses cross-trained in intensive care and additional extracorporeal therapies.

The program performs approximately 200 therapeutic procedures annually, including plasma and red blood cell exchange, high volume plasma exchange, and white cell depletion.

We are actively expanding our program to include cellular procedures while pursuing FACT accreditation, underscoring our commitment to quality and compliance with national standards.

Our team's expertise and integrated approach position us as a vital resource in both therapeutic and cellular collection services.

The Apheresis Quality and Regulatory Coordinator will play a key role in supporting our FACT accreditation efforts and maintaining a robust Quality Management System (QMS).

This position ensures that all aspects of the program meet regulatory, accreditation, and institutional standards.

Key Responsibilities


* Lead and maintain the Quality Management Plan (QMP) in alignment with FACT standards.


* Coordinate internal audits, document control, and corrective action plans.


* Support SOP development, review, and updates across clinical and collection workflows.


* Facilitate staff training and education on quality and compliance topics.


* Serve as liaison with regulatory bodies and accreditation inspectors.
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