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The ideal candidate will have a deep understanding of food manufacturing processes and regulatory requirements, including SQF, HACCP, FDA, Quality, GMP, Batch Record Review, QMS, and Dairy.
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Responsible for batch record review and release of finished products. Contributor to various QA Quality Program functions when needed (e.g. Deviation, CAPA, Supplier Management, Customer Complaints, biennial review, internal/external auditing, risk management, non-conformances, product returns, raw material review and release, etc.
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Knowledge and application experience with batch record review, product disposition/release, change control, Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations.
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Works with cross functional team to facilitate NPI process fit; including batch record review, assistance with area engineer to ensure process fit within BU3 manufacturing suites, work with Tech transfer to produce standardized and efficient clinical batch record.
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Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents. Tracks status of Executed Batch Records and maintains established deadlines for completion of review and corrections.
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At least 3 years of experience with Batch record review, Batch disposition, deviation investigations and CAPA tracking; Review and approve external vendor GMP documents, including but not limited to, drug substance and drug product batch records, packaging and labeling records.
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Keywords: GMP, GLP, GXP, GCP, batch record management, batch record review, full-process manufacturing, cell therapy, deviations, junior role, maintenance, calibration, FDA, EMA, biopharmaceuticals, quality assurance, QA.
$29 - $35 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Train on and Support Controlled (Grade C and D) and Aseptic (Grade A and B) processing areas with Line Clearances, QA oversight, and batch record review (MBR and EBR). Perform batch record review for all production steps - ensure compliance to established and validated parameters.
$46,265 - $110,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The position requires collaborating with multiple departments regarding metrics, exception reporting and knowledge of regulatory documents and cGMPs∯*∯ The Batch Record Reviewer works under the direct supervision of the QA Batch Record Review Supervisor and senior Quality Assurance management.
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Develop departmental goals and ensure the timely completion of all deliverables, including batch record review. The QA AD will also be responsible for overseeing QA activities, ensuring that batch records are reviewed promptly, and that the Quality Management System is effectively implemented, including Quality review and approval of document changes, deviations, change control assessments, and Quality risk management assessments.
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You'll complete QA processes including batch record review, sampling and inspection of incoming materials, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives.
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Supports disposition activities for manufactured products in support of Commercial/Clinical Product, including Master Batch Record review, Executed Batch Record review, resolution of comments/issues and Certificate of Analysis review.
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Communicate errors and deviations identified during batch record review. Review of manufacturing batch records and product release documentation under tight deadlines with impact on patients and clinical teams for early phase I/II first-in-human clinical development.
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As the Specialist QA II you will be responsible for shop floor monitoring, clearance, and record review during aspects of parenteral manufacturing which includes, but is not limited to raw material release, compounding, aseptic filling, lyophilization, inspection, labeling, and packaging.
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Responsible for, but not limited to, inspecting, and receiving human and porcine tissue, batch record review, cleaning, cycle count, product/tissue quarantine, media change and disposition activities.
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