Quality Assurance Specialist I, Raw Material Release [Contract to Hire]

Iovance Biotherapeutics Inc.•Philadelphia, PA

58d•Onsite

About The Position

The Quality Assurance Specialist I, Raw Material Release role will support review of documentation and support releasing of raw materials, components and manufacturing kits.

Requirements

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.
Working knowledge of cGMP regulations.
Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
Attention to detail.

Nice To Haves

Prior experience in cell and gene therapy preferred.
Knowledge of QMS systems is a plus.

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 of documentation associated with Raw materials, components in support of manufacturing operations
Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition, as required.
Review of deviations as assigned.
Revision of documents as assigned.
Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies, and observations to management.
Disposition incoming materials.
Preparing supporting documentation for release of materials.
Issuance of labels, as required.
Support lot closure
Other projects as assigned.