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The role reports to the Senior Manager IT Quality and is within the IT Quality & Regulatory Assurance organization. Drives the GXP Inspection Support and defends the validation strategies to internal auditors, regulatory authorities, and other certified bodies.
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Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
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Familiarity with inventory control, OSHA, HACCP and other regulatory requirements. Discuss associate performance with Sr. Warehouse Managers and create plans to address gaps. Participate in building high-performing teams by interviewing and hiring warehouse personnel, in conjunction with Sr. Warehouse Managers.
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Direct: Union and/or non-union warehouse on-floor associates (Loaders, Selectors, Receivers, Forklift drivers, etc.) PCQI certification a plus. Review performance, coach on productivity and safety targets, and deliver disciplinary action.
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Bachelor's degree in mechanical or aerospace engineering Job Description: Researches, plans, analyzes, designs, and develops mechanical products such as ammunition handling systems, structures, gun systems, missile launchers, mechanisms, and other devices.
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As a Sr. Advanced ASIC Design Engineer, you will be responsible for providing customer technical support for Honeywell's Space Microelectronics portfolio of Radiation-Hardened ICs. This includes supporting products, processes, and technologies in alignment with the organization's business strategies.
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Completes Resident Assessment Protocol (RAP) documentation based on regulatory requirements, MDS information obtained, and in accordance with professional standards of practice. RESPONSIBILITY: To assure timely completion of the MDS with a focus on accuracy, case mix maximization, and regulatory compliance.
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Ensures compliance with regulatory operations such as Change controls, quarterly GxP sign offs as agreed with IT and business and participates in relevant governance meetings. · Familiar with data integrity principle for regulatory compliance (i.e., user access, audit trail, computer system validation) would be a plus.
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Job Title: Eng-Sr -Mech. Must have working knowledge of creating moderately complex solid models and mechanical designs using CAD systems, preferably PTC Pro- E or CREO. This client is a US Federal Government contractor and is legally required to hire US Citizens.
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All positions must strive to support WFM core values and goals, promote national, regional, and store programs and initiatives, and ensure adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department.
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You will be a primary finance business partner support to PVH Quality, OU Operations, and Regulatory leadership team. Business partner to the Quality, OU Operations, and Regulatory leadership teams providing financial analysis and support that drives business decisions.
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The Project Manager – Blood Products is responsible for the project management of new product development, regulatory submission and commercialization activities of the freeze-dried plasma product.
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Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
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Ensure comprehensive strategic/continuous improvement plan exists for regulatory compliance activities. Perform as a leader for a complex operating plant with complex regulatory requirements combined with significant legacy environmental history.
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Without appreciable direction exercises considerable latitude in determining ongoing technical support for project activities within areas such as Operations, Maintenance, Testing/diagnostics and Regulatory.
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regulatory job Title: sr Company: Planet Pharma in Osseo, MN
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