Specialist GXP-QA - Applied Gene & Cell Therapy Center

Cincinnati Children's•Orleans, MA

14d•Onsite

About The Position

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 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 Completion of Application You will be asked to fully complete each page of the application to the best of your knowledge. Failure to complete all parts of the application will result in a delay in processing and/or rejection of the application. Need Assistance or Accommodation? Assistance with Application: For assistance or technical support, email [email protected]. Accommodation: We provide reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act and applicable state and local law. If you require an accommodation in the application process, email [email protected].

Requirements

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

Responsibilities

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.
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.
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.
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.