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Author and review SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations. Closely partner with peers for rapid review of batch-related documentation.
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Support process operations by performing support specific and real time floor service tasks (i.e., kitting and kit cleaning, inventory management and data entry, sample management and data entry, aseptic behavior for cleaning of equipment, and cryopreservation) according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.
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Batch manufacturing experience in a cGMP environment highly desired. The function of a Senior Chemical Process Engineer is to ensure that process operations in the production and small scale facilities perform in a safe, predictable, and consistent manner, and are in keeping with safety, environmental, cGMP, and economic concerns in accordance with company and regulatory requirements.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Review batch record (MPI’s) to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately. Must have knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Coating Operator is responsible for safely operating the coating equipment and to ensure Coating Operations are completed in adherence to Standard Operating Procedures and maintaining 100% cGMP & compliance.
$16 - $20 an hourFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Complete all documentation required for packaging in a cGMP compliant manner, including Packaging batch records (Travelers), box labels, room and equipment logbooks, and in-process documentation.
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This position requires the coordination and writing of cGMP manufacturing batch records or batch summary. technical services team to support process & technology transfer (e.g., mAbs, fusion proteins, mRNA, new.
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Compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP. Archiving of executed batch records and associated documentation.
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Quality:Each individual is responsible to meet fundamental cGMP requirements relating to their conduct and work practices to ensure the SISPQ (Safety, Identity, Strength, Purity, Quality) of the products manufactured at Evonik Tippecanoe Laboratories.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Ability to maintain compliance in all SOP, cGMP, EHS and other training curriculum as assigned. In this position, you will be responsible for performing operations related to the manufacturing of pharmaceutical products through equipment set-up, operation, clean up and maintenance in compliance with all regulatory cGMP requirements and company policies and procedures.
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Authors and reviews technical reports, process tech transfer summary reports, master batch records, product and equipment specifications, and protocols in support of tech transfer and cGMP activities.
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Participates in the completion of work orders, including batch record documentation per cGMP (current good manufacturing process). Completes training, including cGMP and safety training in a timely manner.
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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.
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Inspection of initial product produced as it is bottled and released off the production line, checking for correct content, volume fill level, bottle size, verification of label, correct batch number, expiration date, verification packaging conforms to customer purchase order specs.
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Routinely performs tasks in relation to cGMP, ISO, and Quality requirements including, but not limited to: Following basic and/or advanced Standard Operating Instructions, ensuring proper batch segregation, performing quality inspections, filling out paperwork accurately and timely.
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