Children’s Hospital of Orange CountyOrange, California
$86,258 - $142,334 / year
Work Location Orange, California Work Shift Day – 08hrs (United States of America) Why CHOC? At CHOC, we strive to be the leading destination of children’s health by providing exceptional and innovative care. We are responsible for the overall health of our community’s pediatric population in our hospitals, clinics, and practices. And because of our breadth of care, your career at CHOC can be as diverse and fulfilling as you determine. CHOC’s compensation structure, benefits offerings, and career development programs are geared to helping you achieve your professional and personal goals. Apply now to see where your career at CHOC can take you. Environmental Sustainability Statement Driven by the connection between children's health and a healthy environment, we commit to creating a healthcare model that incorporates environmental sustainability aligned with our mission to protect children's health and patient safety. Job Summary Are you a detail-driven quality professional with a passion for advancing life-saving therapies? We’re seeking a Senior Quality and Accreditation Coordinator to lead and elevate the quality and regulatory efforts across our Bone Marrow Transplant (BMT) Program, Immunotherapy and Gene Therapy Services, and Therapeutic Apheresis.In this pivotal role, you will oversee our quality management and regulatory compliance programs, ensuring alignment with standards from FACT, FDA, NMDP, TJC, AABB, CDPH, and CIBMTR. You’ll work in close partnership with the Laboratory Quality Assurance Manager and multidisciplinary teams to guide all aspects of cell processing—from apheresis and marrow collection to laboratory operations—ensuring full compliance with all regulatory and accreditation requirements.We’re looking for an experienced quality leader who brings: * A deep understanding of regulatory and accreditation standards in cellular therapy and BMT * A commitment to continuous improvement and patient-centered excellence * Strong collaboration, communication, and organizational skills * A passion for innovation in cellular therapies and their potential to transform outcomesJoin us and be part of a mission-driven team at the forefront of cellular therapy, where your expertise will directly impact the quality and safety of some of the most advanced treatments in medicine. Pay Range Minimum $86,258 Midpoint $114,296 Maximum $142,334 Rate of pay is determined by various factors, including but not limited to knowledge, skills, competencies, experience, education, as well as position requirements. Experience * Required: Minimum two years of experience in clinical data management, healthcare quality, hematology/oncology, or cellular‑therapyprograms.* Preferred: Oncology/Hematology, three years of BMT lab processing experience or other relevant clinical experience. Current or previousexperience as an assessor for the Foundation for Accreditation of Cellular Therapy. Education * Required: Bachelor’s degree in health science, nursing, biological sciences, or related field.* Preferred: Master’s degree in Science, Nursing, Laboratory Science, Business or closely related field. Special Skills * Required: Proficiency in quality systems and regulatory standards (FDA 21CFR 200, 210, 600, 1271; FACT; NMDP; AABB).Strong knowledge of oncology/stem cell transplant terminology, infectious disease testing, transplant outcomes, and data management. Excellent organizational, written, verbal, and interpersonal communication skills. Strong knowledge of document control systems for managing, editing and publishing standard operation procedures. Project management and presentation capabilities. Intermediate to advanced skills in Microsoft Office and electronic documentation systems.* Preferred: Advanced knowledge of Current Good Tissue Practices (cGTP) and Current Good Manufacturing Practices (cGMP). Includingpoint-of-care manufacturing. Intermediate to advanced knowledge of cell therapy clinical and translational research trials. Licensure * Required: One of the following: CLS, MLT, CABP (AABB), or CA Registered Nurse.* Preferred: CA Registered Nurse license or CQA(ASQ) Work Environments - Functional Demand: Light - Moderate energy level Lift and carry 25-35 lbs. Push/pull 50-100 lbs. (ie. empty bed, stretcher). Physical Activity Requirements: Bending, Carry Objects, Climbing, Keyboard use/repetitive motion, Pinching/fine motor activities, Push/Pull, Reaching forward, Reaching overhead, Sitting, Squat/kneel/crawl (Squad & Knee), Standing, Talk or hear, Taste or smell, Twisting, Walking, Wrist position deviation Physical Activity Lifting Lifting (Floor to waist level) - Occasional 0-35%, Lifting (Waist level and above) - Occasional 0-35% Sensory Requirements: Color Discrimination, Depth Perception, Far Vision, Hearing, Near Vision Environment Requirements: Airborn Communicable Disease, Bloodborne Pathogens, Chemical, Dust Particular Matter, Extreme Noise Levels, Extreme Temperatures, Radiation, Uneven Surfaces or Elevations Non-Discrimination Statement: CHOC does not discriminate on the basis of age, race, color, religion, national origin, ancestry, marital status, genetic information, disability, sex, gender (including pregnancy, breastfeeding, childbirth, lactation or related medical conditions), gender identity or expression, medical condition, sexual orientation, veteran status, military or uniformed service member status, or other protected characteristics in accordance with state and federal laws. We encourage individuals from all backgrounds to apply for positions at CHOC, even if your experience doesn’t align perfectly with the listed qualifications for a particular role, as your unique experience may be a great addition to our culture for another one of our opportunities. If you desire support or accommodations throughout the Talent Acquisition process, please inform your Talent Acquisition Partner.
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