Coordinator-GXP QA - Regulatory Affairs

Coordinator-GXP QA - Regulatory Affairs-154037

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.

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.

Work collaboratively with diverse teams and interface effectively with internal stakeholders, as a contributing team member in support of institutional initiatives.

Coordinates activities as needed.

Qualifications

EDUCATION / EXPERIENCE

Required :

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

Research

Shift

Day Job

Job Type

Standard

Department

170105 - Regulatory Affairs

Employee Status

Regular

Weekly Hours

Salary Range

21.21-30.50