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Own, Investigate, and document OOS test results and deviations, and investigations for cGMP Quality Control. Execute analytical quality control release, stability and complaint (follow-up) testing for raw materials, in-process and final products to ensure compliance with cGMPs, GLPs, GDPs, Quality Assurance Procedures, SOPs and established deadlines.
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Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems - Veeva, Theia, LIMS, IDBS.Operate as a part of a team with experience supervising and or training individuals in a functional, safe working environment while maximizing laboratory efficiency.
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Apply Advanced Product Quality Planning techniques such as Failure Mode Effects Analysis, control plans and Measurement System Analysis to evaluate the producibility of new products and stability of production processes.
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Develops queries and analytical tools for use in quality improvement and decision support. Provides consultation, design, and development services, requiring data collection and presentation, reports, and other specialized documents for clinical quality improvement and regulatory compliance.
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This role requires an understanding and working knowledge of classic control theory and vector control of electric motors; familiarity with IGBT- or MOSFET-based power electronics inverters used as motor drives (including rectifier front end); and familiarity with induction and/or permanent magnet electric machines.
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The Control Systems section within the Sensor Power and Analog Design Department (SPAD) has an exciting employment opportunity for a Senior Engineer with motion control experience. Understanding and working knowledge of classic control theory and vector control of electric motors.
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Support Manufacturing, Quality Control and Assay Development by shadowing the process and providing beneficial feedback and knowledge on the process. Collaborate with Manufacturing, Assay Development, Engineering, Technical Support, and Quality Control groups to support resolution of complex issues.
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Interface with multiple departments at multiple locations (Production Group, Quality Control, Quality Assurance, Research Products, Operations and Logistics) and external consultants to ensure compliance with the company's Quality Management System, cGMP, and ISO standards.
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This individual will support method development, validation, and quality control activities conducted at Sarepta Andover in compliance with cGMP regulations. Author and review quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites.
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Quality certifications like ASQ Six Sigma Green Belt or Black Belt, CQE, etc. Job Title: Quality Systems Engineering Manager. Excellent knowledge of Quality Management System (QMS) in high volume semiconductor, or electronics manufacturing environment.
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Job Title: Control Room Operator. Experience in troubleshooting support of electric distribution operations using control room computer systems assets, remote switching and/or dispatching of electrical distribution equipment via SCADA, preferred.
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Operates Computer/office machines Travel Estimate Up to 5% Education and Job Qualification B.S. or equivalent experience Excellent oral, written and interpersonal communication skills Ability to follow specific instruction (i.e. written SOPs) Experience: Minimum 5-7 years of related experience Working knowledge of cGMP/GLP Fundamental knowledge of chemical principles and analytical instrumentation Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.
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Additionally, they will review and interpret engineering drawings, CAD data, and specifications to determine inspection requirements, collaborating with cross-functional teams to enhance quality processes.
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Responsible for the proper operation and documentation all building systems, to include without limitation, fire alarm, fire sprinkler, security alarm, emergency lighting and signage, emergency egress, building access control, monitoring and recording, fuel distribution, elevators, generators, communications, disposal, sanitary, domestic water, plumbing, electric, heating, cooling, and ventilation.
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This involves the development of a control system architecture, selecting the components to be used, detailing schematic diagrams and system documentation, programming controllers (PLC, DCS, RTU), programming the process visualization (HMI/SCADA), developing databases for archiving/displaying historical system data and implementing/commissioning the control system at the client's facility.
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cgmp quality control jobs Company: Randstad Usa in Andover, MA
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