Provides departmental administrative support, management interface and quality assurance expertise to ensure departmental compliance with regulatory and accreditation agencies. Supports quality assurance activities for both the Stem Cell Transplant and Heme Malignancy Programs within the Seidman Cancer Center. Implements and facilitates quality goals based on the departmental Quality Plans. Essential Functions. Quality review of medical records associated with cellular therapy procedures and tre... more details
Position Summary
Provides departmental administrative support, management interface and quality assurance expertise to ensure departmental compliance with regulatory and accreditation agencies. Supports quality assurance activities for both the Stem Cell Transplant and Heme Malignancy Programs within the Seidman Cancer Center. Implements and facilitates quality goals based on the departmental Quality Plans.
Essential Functions
Quality review of medical records associated with cellular therapy procedures and treatments.
Assists with writing, revising, and maintenance of standard operating procedures and associated forms and worksheets; facilitates reviews and approvals; ensures protocol compliance
Assists with preparation and coordination of internal and external audits and prepares outcomes for presentation at the monthly programmatic quality meeting
Collaborates with interdepartmental staff on quality improvement projects. Reviews and facilitates incident/accident/errors. Corrective action/follow up
Ensures programmatic compliance including but not limited to FDA, FACT (Foundation for the Accreditation of Cellular Therapy), NMDP, CIBMTR, ODH, JC.
Required For All Jobs
Performs other duties as assigned.
Complies with all policies and standards.
For specific duties and responsibilities, refer to documentation provided by the department during orientation.
Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Qualifications Education
Bachelor's Degree in science, healthcare, quality, or related discipline Required
Work Experience
2 years professional experience in a healthcare related field, laboratory or experience in quality assurance Required and
Prior experience with process/performance improvement Required and
Previous experience working in a cellular therapy program Required
Knowledge, Skills, & Abilities
Excellent organizational & communication skills. Required
Detailed oriented and be able to multi-task and handle a large volume of work. Required
Must possess high degree of computer skills, complex math skills, proficiency in Microsoft Required
Good written and verbal communication skills. Required
Knowledge of cellular therapy, FDA, GMP, and GTP regulations. Required
Office and outlook, PowerPoint, excel, and working with data bases. Required
Excellent oral and written communication skills Required
Excellent customer service orientation. Required
Demonstrated ability to manage processes and/or activities of various and diverse employee groups, interacting effectively and professionally. Required
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