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Keep accurate and organized records of batch record review activities and findings. The Batch Record Coordinator is responsible for the creation, assessment, and issuance of batch records in accordance with cGMP guidelines.
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This includes managing and performing supplier audits, developing audit agendas, writing audit reports, approving audit responses, developing/reviewing supplier quality agreements, performing batch record review/approval to support DS and DP disposition activities.
$100 - $130 an hourPart-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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Perform batch record review and release for finished product, raw materials, intermediate solutions, and services. Experience working in a Quality Department/Life Sciences-Regulated environment, including experience independently conducting internal audits, document review from a technical and quality perspective, batch release, incoming inspection.
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Microbiology, Environmental monitoring, batch record review, technical writing, Quality assurance. Microbiology,Environmental monitoring,batch record review,technical writing.
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Ideal candidates will be local, with 8+ years of relevant experience supporting Batch Record Review and Product Disposition. Strong background in Batch Record Review experience required.
ExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
$35 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Performs SAP transactions required to document Batch Record review. Batch record review experience. Looking for GMP/PHARMA/BIO-PHARMA profiles with batch record documentation experience.
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Perform batch record review on daily quality control line paperwork. GMS and QMS site leader. Perform batch record review on daily quality control line paperwork. Pharmaceutical packaging experience is a plus.
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Batch Record Review for media fills, compounding/filling/capping, visual inspection, labeling and packaging activities. Review of QC test data for incoming bulk, raw materials and components, and release testing for products manufactured at the site.
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Batch Record Review of drug substance. Review of QC Analytical and Microbiological data. Active participation at the Deviation Review Board, Site Quality Council and other relevant forums pertinent to product quality review.
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Manage the Product Release Program, batch record review process, metrics, and customer CofAs. As the Quality Systems Manager, you will play a pivotal role in championing daily activities for quality excellence.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Manage all Quality Operations activities, including Batch Record review and approval, final product disposition, and approval of Quality Events (e.g. OOS, deviations and nonconformances) prior to product release.
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About Gerresheimer Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems.
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Location/Division Specific Information St. Louis MO / Pharma Services Group This is a non-supervisory role, reporting to the QA Supervisor Batch Record Review and Release at the Thermo Fisher St. Louis site.
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