Description:
Expected Starting Salary Range: 21.21 - 25.86
This position will join Cincinnati Children's Hospital's research administration, within the Office of Research Compliance and Regulatory Affairs, specifically providing regulatory support and quality assurance oversight to the Cincinnati Children's Hospital's Translational Core Labs Cell & Gene Therapy manufacturing operations to ensure compliance with FDA Good Manufacturing Practices and Good Tissue Practices. The Translational Core Labs manufactures products suitable for early phase clinical trials for both academic and pharmaceutical sponsors.
REPRESENTATIVE RESPONSIBILITIES
·Regulatory Knowledge & Oversight
Under the direction of more senior QA staff and within a limited and 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 and operational procedures are compliant with regulatory directives.
·Quality Assurance
Designs, oversees and implements document control activities. May conduct specific reviews of defined documents under direct supervision of more senior QA staff. Issues documents for product release. Coordinates audits, training, discussions and process improvements.
·Teamwork, Collaboration & Leadership/Management
Work collaboratively with diverse teams and interface effectively with internal stakeholders, as a contributing team member in support of institutional initiatives.
·Training & Development
Coordinates activities as needed.
Qualifications:
EDUCATION/EXPERIENCE
Required:
·High school diploma or equivalent
·3-5 years of work experience in a related job discipline OR equivalent combination of education and experience
Preferred:
Unique Skills:
Cincinnati Children’s is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are 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/AA/M/F/Veteran/Disability