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Provide on-the-job training, emphasizing cGMP compliance. Supervise, and perform as needed, the creation and revision of production documents in order to maintain cGMP compliance and efficiency.
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Strong understanding of regulatory guidelines (e.g., FDA, cGMP, ISO) related to environmental monitoring and equipment qualification. Bachelor's degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry) or equivalent work experience.
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5 or more years work experience in a cGMP regulated environment preferably in biologics manufacturing Prefer experience knowledge working with Single Use Technologies or modular operations. Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
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POSITION SUMMARY: Manufactures in-vitro diagnostic products (controls and calibrators) used in the clinical laboratory, following cGMP. Completes associated manufacturing documentation and participates in continuous improvement projects.
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May work in the clean room environment that requires gowning in the form of hospital scrubs coveralls gloves and steel toe boots be worn. The OSUT will employ a ballroom design utilize single-use technology new analytical techniques and digital manufacturing systems to deliver a best in class bioprocess facility.
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Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
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The purpose of this position is to perform tasks and operations relevant to the bulk formulation and/or filling operations required for sterile production of liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing.
$20 - $24 an hourFull-timeExpandApply NowActive JobUpdated 0 days ago - UpvoteDownvoteShare Job
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Skellig is seeking an Automation Engineer with DeltaV and cGMP experience to support our clients across North America. Skellig is seeking an Automation Engineer with DeltaV and cGMP experience to support our clients across North America.
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The purpose of this position is to participate in tasks related to the visual inspection of manufactured liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing as well as other types of visual inspection activities, as required.
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Follow cGMP and ISO standards or guidelines as they apply to manufacturing. Serve as a role model for cGMP manufacturing. Follow cGMP and ISO standards or guidelines as they apply to manufacturing.
$20.16 an hourExpandApply NowActive JobUpdated 0 days ago - UpvoteDownvoteShare Job
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5 or more years of work experience in a cGMP-regulated environment, preferably in biologics manufacturing. May work in a clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves, and steel-toe boots be worn.
$30 - $80 an hourExpandApply NowActive JobUpdated 1 days ago - UpvoteDownvoteShare Job
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2+ years of experience in ISO or cGMP-regulated manufacturing environment. Drives Practical Process Improvements (PPI) with a high level of team member involvement and engagement. Accountable for ensuring system data integrity for manufacturing data elements (BOM, Routing, ACQ, Lead Times.
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Implementing improvements in areas such as cGMP training, core competencies, technical skills, safety, and performance management. Experience on demand planning, inventory management, sourcing, purchasing, and delivery performance.
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Ensure audits of the existing company Quality Systems and procedures are executed and ensure all findings are addressed appropriately per cGMP regulations and for continued improvement to the company Quality System.
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Detailed cleaning of equipment/facilities to MSP/cGMP standards. Bulk processing and filtration involving monitoring processing parameters (i.e. pH, weights, separation, assay results. Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals.
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cgmp job in Carlsbad, CA
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