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Keyword search string: Pharmaceutical, cGMP, manufacturing, CNC, and machine operator, SOP, packing and batch record instructions. Ability to maintain 100% compliance in all SOP, cGMP, EHS and other training curriculum as assigned.
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Automation experience in a cGMP manufacturing environment such as pharmaceutical, nutraceutical, or equivalent process-related industry preferred. Lead all controls aspects of the development of new (or existing) cGMP manufacturing equipment intended for production or product development.
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Support Hoxworth Blood Center’s safety, cGMP and Quality Plan. May provide direct and/or indirect supervision to exempt and non-exempt staff (i.e., hiring/firing, performance evaluations, disciplinary action, approve time off, etc.
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The QA Technician will support the implementation and enforcement of the Quality and Food Safety Management System requirements throughout all of the manufacturing process in order to ensure compliance with the company policies, FDA cGMP, and industry standards.
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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide.
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Experience in cGMP or pharmaceutical, medical device, or related manufacturing industry. Minimum 2 years’ experience in QC, QA, Analytical Development, Process Engineering, Engineering services or OSD Manufacturing.
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Maintain equipment files and document maintenance activities in compliance of SOPs and Good Manufacturing Procedures (cGMP). Sr. Manufacturing Equipment Maintenance Technician will problem solve, repair, and perform preventative maintenance on GMP packaging and serialization equipment.
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Support Hoxworth Blood Center’s safety, cGMP, and Quality Plan in coordination with the Division Director, Quality and Regulatory Affairs. Experience in daily production of cleanroom environments, as well as interviewing, selection, hiring, and training of new employees with knowledge in cleanroom environment and regulatory framework in accordance with cGMP, FDA, and ISO regulations pertinent to the environmental control in ISO7/8 facilities is crucial.
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This position is responsible for performing operations related to the manufacturing and/or packaging 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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ExperienceMinimum 2 years’ experience in QC, QA, Analytical Development, Process Engineering, Engineering services or OSD ManufacturingExperience in cGMP or pharmaceutical, medical device, or related manufacturing industryEquivalent combinations of education, training, and relevant work experience may be considered.
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Knowledge of GLP, cGMP, and ICH guidelines; Compile and review all results from instruments and Watson-LIMS database for report writing; Discounts on local sports games, local fitness gyms and attractions Official Sponsor of FC Cincinnati.
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We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Discounts on local sports games, local fitness gyms and attractions.
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If you have prior experience in an FDA or cGMP environment that is a BIG plus. Ability to complete all necessary paperwork and Red Zone documentation. Reading skills to follow fill line work orders and customer specifications.
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Staff - Advises supervisor and the quality assurance manager of any cGMP violations and keeps supervisor abreast of low levels of raw materials and supplies. The position is one of assisting in the manufacture of the Company's products pursuant to Standard Operating Procedures (SOPs) in compliance with current Good Manufacturing Procedures (cGMP) as regulated by the U.S. Food and Drug Administration.
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Provides leadership that promotes safety, environmental and cGMP compliance. Leverages technical skills and provides practical solutions to improve API processing efficiency while maintaining a high level of cGMP compliance.
$152,000 - $228,125 a yearExpandApply NowActive JobUpdated Yesterday
cgmp job in Cincinnati, OH
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