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This position will be responsible for providing operational excellence continuous improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous improvement initiatives with various site functions to support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements.
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Our client, a leading pharmaceutical company, is hiring a Clinical Manufacturing Associate on a contract basis. Clinical Manufacturing Associate. Experience within cGMP/FDA regulated industry.
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Job Description: Clinical Manufacturing Associate. Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique. Production of blood component lots through cell culture, harvest, and cryopreservation.
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Advanced understanding of cell culture. Background to include an understanding and application within industry of biology, chemistry, medical or clinical practices. Assist tech transfers in and out of the clinical facility.
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Technical writing capability. Adhere to the production schedule ensuring on-time, internal production logistics. Bachelor's degree in an applicable science or engineering field and a minimum of 2 years relevant experience.
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Immediate need for a talented Clinical Manufacturing Associate. Immediate need for a talented Clinical Manufacturing Associate. Please review the job description below and contact me ASAP if you are interested.
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Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures. Associate engineer II demonstrates working knowledge of equipment and processes in facilities, HVAC, or utility systems or have skills within manufacturing and/or packaging of pharmaceuticals from a project delivery role.
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Perform quality assurance support of manufacturing, laboratory and warehouse areas to ensure compliance with cGMP requirements and company procedures. Review of documentation supporting batch, warehouse, metrology, engineering and validation activities to ensure they are complete and in compliance with company policies and procedures, and cGMP requirements.
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Executes the defined continuous improvement program through the use of lean and six sigma manufacturing methodologies such as standard and standardized work, metrics, visual tools, PDCA, Kanban, pull systems, SMED, pareto, FMEA, A3 thinking, time studies, poke yoke, process mapping and others.
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Operations experience in pharmaceutical manufacturing to cGMP standards including extensive knowledge of regulatory guidelines and validation practices. Knowledge of suppliers, industry trends and emerging players in global pharmaceutical manufacturing services.
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Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
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Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
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Record production data and information in a clear, concise, format according to proper GDPs. Weigh and measure in-process materials to ensure proper quantities are added/removed. Work in a team based, cross-functional environment to complete production tasks required by shift schedule.
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Motivated, team consciousness individuals are needed to fulfill job requirements. Develop a high level of technical knowledge of project(s) No direct reports will be assigned to this job role. Detailed Position Responsibilities.
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Certification in lean manufacturing principles and Six Sigma tools. Demonstrated success negotiating complex supply and toll manufacturing agreements with external suppliers. Manage inventory risk assessment process for inventory located at manufacturing site.
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manufacturing associate cgmp jobs in Piscataway, NJ
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