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Handles and inspects components and filled product in accordance with Current Good Manufacturing Practices, Operating Procedures and Safety Regulations Documents and communicates functions and duties necessary to complete the manufacture of products produced in the Sterile Filling Department.
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Checks product lot number information, documents in the batch record where applicable, and reviews Master Batch Records for accuracy at all stages in the manufacturing process - Formulation, Filling, Inspection, and Packaging.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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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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Filling activities in non-controlled areas: tube and bottle manufacturing. We have a contract opportunity for a 3rd Shift Manufacturing Filling Operator in Lombard IL. This is a contract position with a real possibility of going contract to hire.
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Perform packaging activities including but not limited to label generation, visual inspection, heat sealing, and utilizing packaging equipment. 3rd Shift: 10:00PM - 6:30am shift (Monday - Thursday) overtime is needed based on work volume.
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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.
Full-timeExpandUpdated 12 days ago - UpvoteDownvoteShare Job
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This includes formulating bulk product and culture media, completing cleaning and sterilization of equipment, setting-up and operating filling equipment, staging and loading components and bulks, setting-up and operating inspection equipment, setting-up and operating nitrogen tunnels for freezing, completing Iyo cabinet operations, staging and loading packaging components, setting-up and operating packaging equipment, and completing associated batch record and logbook documentation.
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Calculates percent defective on inspection results and reconciles components on batch record. Responsible for visually inspecting filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP.
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As the QA Operations Manager, this position will drive quality execution across the operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for the Plainville manufacturing facility.
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Work with site leadership team to build subject matter expertise across functions in the areas of compounding, sterilization, and single-use assemblies for filtration and filling, device assembly, and visual inspection.
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Files contain such information as lot and batch numbers, cylinder maintenance and inspection logs, and materials required by the F.D.A. + Frequently and repetitively removing cylinders from containers (floor) and placing onto the inspection table (waste high), then to the filling rack (2ft to 6ft high) after per-fill tasks are completed.
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Job SummaryResponsible for visually inspecting filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP). The production inspector will work in the Capping Department and on the off-line inspection area and therefore must be knowledgeable of procedures and equipment in each area.
Full-timeExpandUpdated 14 days ago
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