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Sr. Quality Engineer. 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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Contributor to various QA Quality Program functions when needed (e.g. Deviation, CAPA, Supplier Management, Customer Complaints, biennial review, internal/external auditing, risk management, non-conformances, product returns, raw material review and release, etc.
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Six Sigma Green/Black Belt, Quality Auditor certifications a plus. Our breadth of offerings across the entire semiconductor value chain help our customers solve their most difficult yield, device performance, quality, and reliability issues.
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The ISO Quality Specialist will be responsible for development, implementation, and maintenance the organization's Quality Management System for non-GMP products. The primary responsibility of the Quality Specialist is to maintain the adherence to quality standards for non-GMP products.
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The Quality Control Analyst will work within the QC team, testing gene therapy products utilizing cell-based assays (Potency assay) in support of clinical and commercial lot release and stability activities.
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Job Title: Specialist, Quality Engineering Job Code: 9548 Job Location: Wilmington, MA Job Description: We are looking for an experienced Quality Engineer who is excited about space and technology applications to join the L3Harris Imaging Division in Wilmington, MA. This QE will support the new product implementation of space based imaging systems.
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Drive continued efficiency improvements through the effective use of metrics, 5S, and the PPI process Recommend and implement changes in manufacturing procedures to improve product quality and production efficiency.
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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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The Director, CMC QA will report to the Executive Director of CMC QA and be responsible for maintaining strategic responsibility over QA Operations, developing and implementing Ultragenyx CMC Quality approach for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality.
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Responsible for Quality System records associated with analytical testing (change control, lab investigations, OOS, deviations, and CAPAs)Establish and maintain Sarepta’s specifications and sampling plans for in-process, drug substance, drug product, and stability.
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What You’ll Do: Reporting to the Lead Clinical Research Associate, the CRA II/Sr. CRA will perform quality and compliant Investigator site monitoring and relationship-driven Investigator site management in line with MapLight’s SOPs, our Mission, Vision, and Values, as well as industry quality and regulatory best practices (ICH GCP.
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HemaCare’s vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections.
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Author, review and provide assessment as analytical SME for quality events, including OOS, deviations, investigations, and change controls. This role requires strong technical expertise, strategic thinking, and collaboration with internal and external teams, including Process Development, Manufacturing, Quality, Regulatory, Facility, partners and vendors.
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Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP preferred.
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Must have experience with Day Hap (MA Health) system and DDS (HICSIS)Quality AssuranceProvide input in programs and preparation for CARF, DDS survey and annual DMA audits. About the Job: Job responsibilities:To assure the highest quality of services to the people in our day habilitation programs.
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