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QA inspectors/auditors, batch record preparation, batch record review, document change control, training, CAPA and quality metrics. Review batch record (MPI) to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately.
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The Quality Assurance Specialist will be responsible for supporting quality functions such as line clearance, batch record review, label issuance, raw material release and facilitating timely release of production lots.
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The Quality Assurance Document Control individual acts as the primary liaison to our customer’s quality assurance groups for batch record review and release. Experience with inspections or Batch Record Review a plus.
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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.
$37,220 - $65,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Those functions may include but is not limited to the oversight and approval of laboratory protocols and reports, data review, batch record review, deviations, product complaints, change controls, and CAPAs using the quality management system.
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The Supervisor will provide overall Quality Assurance support inclusive of but not limited to review and approval of room qualification protocols/reports, line clearance, ongoing environmental monitoring/ cleaning documentation, APV’s / PPQ’s, routine production, batch record review and release of iPBMCs∯*∯ The successful candidate will support and manage the internal team and be on site.
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Provides leadership over the Quality Operations teams that are involved in batch record creation, batch record review, product release, deviation management, change controls, and customer interactions.
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The Quality Auditor performs real-time batch record review during batch processing in order to drive improvements into our Right First Time (RFT) metrics. Performs in-line review of batch record (MPI) to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately.
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Review and confirm PPE attire aligns with batch record instructions. Proactively identify gaps in batch records to mitigate deviations and documentation errors. Review product sampling pages to ensure samples have been taken, labelled, and documented appropriately.
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Perform batch disposition of all GMP materials for release into clinical trials encompassing batch record review, change control and investigation. Prior experience with batch record review and releasing batches.
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The Quality team has a hand in all matters relating to manufacturing, routine batch testing, regulatory updates/requirements, process development, stability/raw material control, and much more.
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Responsible for compliant, thorough, and accurate batch review activities, including QC analytical data and other ancillary batch documentation. Review and approve documentation generated, including master batch records, specifications, protocols, and report.
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Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol. The Quality Assurance Document Control individual is responsible in preparing customer files, review and approve batch records, and release batch records and finished product.
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The individual acts as the primary liaison to our customer's quality assurance groups for batch record review and release. Prefer batch record review experience.
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Bridge to thousands of biopharma companies and their patients. Communicates a clear vision and expectations that create energy, enthusiasm and commitment from others. Ensures PCI generated shipper labels are generated in accordance with customer and regulatory expectations.
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batch record review jobs in Philadelphia, PA
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