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Desired Experience: 4 years of Downstream Process Development, cGMP Manufacturing, Vaccine Production, or similar experience. Desired Experience: 4 years of Downstream Process Development, cGMP Manufacturing, Vaccine Production, or similar experience.
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In this role, you lead a team in applying best practices for the cGMP assembly and packaging of combination pharmaceutical products and manage the integration materials, equipment, and resources for cGMP production activities as they relate to complex device assembly, labeling, and final packaging operations.
$108,000 - $148,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Lead validation and quality engineering activities for internally manufactured products, including validation plans, protocols and reports, maintenance of DMR, change control and CAPA/Deviation investigations.
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Ability to demonstrate mechanical and technical knowledge of cGMP and pharmaceutical packaging standard operating procedures. Ability to demonstrate mechanical and technical knowledge of cGMP and pharmaceutical packaging standard operating procedures.
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Maintaining data integrity and compliance with all SOPs, specifications, and cGMP regulations. Familiarity with cleanroom and gowning processes, cGMP, and sample preparation. The main function of the QC Microbiologist is to perform supportive activities for general lab readiness, conducting critical biological tests, and following SOPs to perform methods using analytical skills and understanding of biological and chemistry techniques and principles.
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Complies with all Good Manufacturing Practices (CGMP) requirements to ensure products are controlled according to the Quality System. Dispositions Non-Conformance Reports (NCR’s) Complies with all Good Manufacturing Practices (CGMP) requirements to ensure products are controlled according to the Quality System.
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Ensure compliance with FDA regulations and CGMP (Current Good Manufacturing Practices) Familiarity with FDA regulations and CGMP requirements. Ensure compliance with FDA regulations and CGMP (Current Good Manufacturing Practices.
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Employee will train and qualify to operate manufacturing equipment, including press operation and encapsulation, in the commercial manufacturing environment. This position sets up, adjusts and troubleshoots pharmaceutical manufacturing machinery and ensures manufacturing operations are completed per standard operating procedure.
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Demonstrated mechanical and technical knowledge of cGMP and pharmaceutical packaging standard operating procedures. Demonstrated mechanical and technical knowledge of cGMP and pharmaceutical packaging standard operating procedures.
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Completes machine set up, operation, tooling changes, adjustments and troubleshooting related to the operation of manufacturing equipment. Responsible for the review of all assigned batch record documentation to ensure error free work.
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High school diploma or equivalent and a minimum of 2 years experience working in a manufacturing, packaging or maintenance/mechanical environment. Maintains manufacturing equipment efficiencies and standards to meet quality manufacturing requirements and established routing times.
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