Specialist GXP-QA - Applied Gene & Cell Therapy Center

Job Responsibilities

• Quality Assurance- Implements defined document control activities. Performs product release activities with oversight as needed. Review and approve official documents, such as but not limited to executed batch records, validation protocols, deviations, standard operating procedures, deviations, etc. related to the quality management system. Supports the conduct of internal and external audits, including vendor qualification audits, with direction. Participate in risk assessments related to manufacturing and testing activities, with direction, and document outcomes. Interacts with manufacturing/operations personnel as needed, including minimal interaction with external stakeholders. Identifies the need for quality improvement activities and works under the direction of more senior personnel to achieve desired outcomes.
• Regulatory Knowledge & Oversight- With limited direction from more senior QA staff and within a clearly defined scope, applies specific elements of federal and state law and institutional policies/procedures/guidance to ensure that all aspects of manufactured products, regulatory submissions (e.g. Drug Master File) and operational procedures are compliant with regulatory directives. Assists in the creation and management of policies and procedures within assigned area.
• Teamwork, Collaboration & Leadership/Management- Work collaboratively with various teams and interface effectively with internal stakeholders, as a contributing team member in support of institutional initiatives. Contributes to the development and execution of a comprehensive quality management system by leading special projects and initiatives within a scope established by more senior leadership.
• Training & Development- Assist in training personnel in Standard Operating Procedures and FDA regulations. May act as a mentor to more junior staff. Serve as the contact for resolution of complex issues, provide education, guidance and work direction. May provide input and feedback to managers on hiring decisions, professional development and performance management.
  
  

Individual typically working under the direction of a consultant or management personnel.

Job Qualifications

• Bachelor's degree in a related field
• 2 years of work experience in a related job discipline
  
  

Primary Location

Burnet Campus

Schedule

Full time

Shift

Day (United States of America)

Department

Applied Gene and Cell Therapy Center

Employee Status

Regular

FTE

1

Weekly Hours

40

• Expected Starting Pay Range
• Annualized pay may vary based on FTE status $56,846.40 - $72,488.00
  
  

About Us

At Cincinnati Children’s, we come to work with one goal: to make children’s health better. We believe in a holistic team approach, both in caring for patients and their families, and in advancing science and discovery. We strive to do better and find energy and inspiration in our shared purpose. If you want to be the best you can be, you can do it at Cincinnati Children’s.

 Cincinnati Children's Is

• Recognized by U.S. News & World Report as a top 10  best Children's Hospitals in the nation for more than 15 years
• Consistently among the top 3 Children's Hospitals for National Institutes of Health (NIH) Funding
• Recognized as one of America’s Best Large Employers  (2025), America’s Best Employers for New Grads (2025)
• One of the nation's America’s Most Innovative Companies as noted by Fortune
• Consistently certified as great place to work
• A Leading Disability Employer as noted by the National Organization on Disability
• Magnet® designated for the fourth consecutive time by the American Nurses Credentialing Center (ANCC)
  
  

 We Embrace Innovation—Together. We believe in empowering our teams with the tools that help us work smarter and care better. That’s why we support the responsible use of artificial intelligence. By encouraging innovation, we’re creating space for new ideas, better outcomes, and a stronger future—for all of us.

Comprehensive Job Description Provided Upon Request.

Cincinnati Children’s is proud to be an Equal Opportunity Employer committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/Veteran/Disability