Quality Assurance Specialist
Key details
- Location
- Cleveland, OH, United States
- Work style
- Onsite
- Level
- Mid level
- Experience
- 2–5 yrs
- Function
- Operations & Strategy
- Focus area
- other
- Posted
- Yesterday
Skills
About the role
Joining our team comes with several benefits, including:
Competitive hourly rate
- Free parking
- Tuition reimbursement
A Brief Overview
Provides departmental management interface and quality assurance expertise to ensure departmental compliance with regulatory and accreditation agencies. Supports quality assurance activities for both the Cellular Therapy and Heme Malignancy Programs within the Seidman Cancer Center. Implements and facilitates quality goals based on the clincial and laboratory program Quality Plans.
What You Will Do
- Quality review of medical and lab 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
- NMDP Executes internal audits, coordinate and prepares for external audits including FACT, FDA, Joint Commission, ODH and commercial partners who provide therapeutic products to the program.
- 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.
Additional Responsibilities
- 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.
Joining our team comes with several benefits, including:
Competitive hourly rate
- Free parking
- Tuition reimbursement
A Brief Overview
Provides departmental management interface and quality assurance expertise to ensure departmental compliance with regulatory and accreditation agencies. Supports quality assurance activities for both the Cellular Therapy and Heme Malignancy Programs within the Seidman Cancer Center. Implements and facilitates quality goals based on the clincial and laboratory program Quality Plans.
What You Will Do
- Quality review of medical and lab 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
- NMDP Executes internal audits, coordinate and prepares for external audits including FACT, FDA, Joint Commission, ODH and commercial partners who provide therapeutic products to the program.
- 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.
Additional Responsibilities
- 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.
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 (Preferred)
Knowledge, Skills, & Abilities
- Excellent organizational & communication skills. (Required proficiency)
- Detailed oriented and be able to multi-task and handle a large volume of work. (Required proficiency)
- Must possess high degree of computer skills, complex math skills, proficiency in Microsoft (Required proficiency)
- Good written and verbal communication skills. (Required proficiency)
- Knowledge of cellular therapy, FDA, GMP, and GTP regulations. (Required proficiency)
- Office and outlook, PowerPoint, excel, and working with data bases. (Required proficiency)
- Excellent oral and written communication skills (Required proficiency)
- Excellent customer service orientation. (Required proficiency)
- Demonstrated ability to manage processes and/or activities of various and diverse employee groups, interacting effectively and professionally. (Required proficiency)
Licenses and Certifications
- Medical Technologist (MT-ASCP) (Preferred)
- Healthcare Quality/CPHQ (Preferred)
Physical Demands
- Standing Occasionally
- Walking Occasionally
- Sitting Constantly
- Lifting Rarely 20 lbs
- Carrying Rarely 20 lbs
- Pushing Rarely 20 lbs
- Pulling Rarely 20 lbs
- Climbing Rarely 20 lbs
- Balancing Rarely
- Stooping Rarely
- Kneeling Rarely
- Crouching Rarely
- Crawling Rarely
- Reaching Rarely
- Handling Occasionally
- Grasping Occasionally
- Feeling Rarely
- Talking Constantly
- Hearing Constantly
- Repetitive Motions Frequently
- Eye/Hand/Foot Coordination Frequently
Travel Requirements
- 10%
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 (Preferred)
Knowledge, Skills, & Abilities
- Excellent organizational & communication skills. (Required proficiency)
- Detailed oriented and be able to multi-task and handle a large volume of work. (Required proficiency)
- Must possess high degree of computer skills, complex math skills, proficiency in Microsoft (Required proficiency)
- Good written and verbal communication skills. (Required proficiency)
- Knowledge of cellular therapy, FDA, GMP, and GTP regulations. (Required proficiency)
- Office and outlook, PowerPoint, excel, and working with data bases. (Required proficiency)
- Excellent oral and written communication skills (Required proficiency)
- Excellent customer service orientation. (Required proficiency)
- Demonstrated ability to manage processes and/or activities of various and diverse employee groups, interacting effectively and professionally. (Required proficiency)
Licenses and Certifications
- Medical Technologist (MT-ASCP) (Preferred)
- Healthcare Quality/CPHQ (Preferred)
Physical Demands
- Standing Occasionally
- Walking Occasionally
- Sitting Constantly
- Lifting Rarely 20 lbs
- Carrying Rarely 20 lbs
- Pushing Rarely 20 lbs
- Pulling Rarely 20 lbs
- Climbing Rarely 20 lbs
- Balancing Rarely
- Stooping Rarely
- Kneeling Rarely
- Crouching Rarely
- Crawling Rarely
- Reaching Rarely
- Handling Occasionally
- Grasping Occasionally
- Feeling Rarely
- Talking Constantly
- Hearing Constantly
- Repetitive Motions Frequently
- Eye/Hand/Foot Coordination Frequently
Travel Requirements
- 10%
11100 Euclid Avenue (82)
11100 Euclid Avenue
Cleveland, 44106
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