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Quality Assurance Specialist

Company: EPM Scientific
Location: Houston
Posted on: August 7, 2022

Job Description:

Position Responsibilities--- Oversight of cellular therapy product quality from procurement through manufacture and distribution to clinical sites.--- Review and approve procedures, QC data, master batch records, and other QA controlled documentation, and associated change controls.--- Provide on-going support to manufacturing operations, review and approve product-related documentation, including batch records, quality control test results, and certificates of analysis, etc. and perform release of final product, as required.--- Support GMP material receipt, inspection and release.--- Ensure all product-related non-conformances and all associated CAPAs are initiated, investigated, and resolved.--- Ensure Change Controls are initiated, evaluated and implemented appropriately for all regulated changes.--- Act as the QA representative on the floor during manufacturing operations and audit operations as needed.--- Contribute to the maintenance and reporting of metrics related to batch record review and product disposition in support of the Management Review.

Skills, Education and Experience Required--- Bachelor's Degree in biological sciences, or related discipline--- Minimum of 3-5 years of Quality Assurance/cGMP Compliance experience in biologics, pharmaceutical, or similar regulated industry (1 year in cell therapy product Quality is highly desired).--- Working knowledge and ability to apply GMPs in conformance to U.S. standards (21 CFR 210/211 and 1271).--- Experience performing batch record review and compilation of batch packages--- Experience with Change Control practices/strategies--- Experience with Non-conformance and CAPA management.--- Knowledge of aseptic techniques and cleanroom behavior/practices.

Keywords: EPM Scientific, Houston , Quality Assurance Specialist, Other , Houston, Texas

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