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Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
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This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance. Must be familiar with use of electronic document management and laboratory information management.
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5 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies.
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The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, action plans, and for corrective and preventive actions (CAPA Program.
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O Bonus: experience with document revisions. o Bachelor's Degree/ 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry. Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.
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Perform and document investigations related to products, processes and quality systems. Provide quality engineering support for quality, manufacturing, design & development, documentation and other product related disciplines.
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Bachelor's Degree or 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry. Must also be familiar with Quality Management Systems (QMS) as well as cGMP and other regulatory requirements.
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Have an understanding of current Air Force acquisition regulations, guidelines, and processes to integrate, communicate, coordinate, organize, and plan technical and acquisition efforts across a broad spectrum of functional disciplines (i.e. Technology development and integrating engineering, program control, foreign disclosure, test and deployment, configuration management, production and manufacturing, quality assurance, and logistics support.
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Maintains on-site records and files per The Perry Group document control requirements. The Bachelors or Associate degree must be in Construction Management, Engineering, or similar technical field.
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5 years of experience in Quality Assurance/Quality Engineering within medical device or pharmaceutical industries. Familiarity with product development lifecycles, including design change and document change control.
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Relevant expertise encompasses hydraulic modeling, hydrology modeling programs, storm drainage systems, equipment selection, specification writing, cost estimation, feasibility studies, master planning, construction document development, and proficiency in AutoCAD and Civil 3D. Our projects encompass diverse municipal water and wastewater system designs.
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BS in Civil Engineering preferred. The ideal candidate should possess a background in project management and hands-on experience in the planning and design of pipelines, pump stations, and water/wastewater treatment facilities.
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Typical projects will be focused on serving the needs of local municipalities with an emphasis on utility work, wastewater collection and treatment, water distribution and treatment, and stormwater management.
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Office Administrator/Engineering Document Controller. Engineering Document Control. Certification in document control or records management (e.g., Certified Document Controller.
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Oversee and document Municipal Street Light Purchase process ensuring the various roles and responsibilities of Operations, IT, Rates and Business Services meet required DTE completion dates. Coordinate Outdoor Lighting related activities with Jurisdictions, Operations, Customer Service, Regulatory, Pricing, Distribution Design, Engineering Standards and IS.
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document engineering jobs in Worcester, MA
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