The Quality Release Specialist will support review of documentation and support releasing of materials and products.
Essential Functions and Responsibilities :
Ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition.
Review of deviations as assigned.
Revision of documents as assigned.
Basic Qualifications :
A Bachelor s Degree in Science, Engineering, or a related technical discipline with at least 2 years of experience in a regulated industry or an advanced degree without experience.
Prior experience in cell and gene therapy preferred.
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