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Ultragenyx has multiple Gene Therapy programs in development, a robust pipeline, and we are building a state of the art GMP manufacturing facility in Bedford, MA. Join our team! The Ultragenyx Gene Therapy team is headquartered in Cambridge and this position will be located within our state of the art GMP Manufacturing facility in Bedford, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy.
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Strong knowledge of engineering standards and all applicable regulatory requirements including: Building Codes, Factory Mutual, Environmental, GMP/GLP, OSHA and ADA. In this position, the ideal candidate will work independently to lead cross-functional project teams through all phases of Infrastructure-Utility, Lab-Office and GMP Manufacturing projects- from scope development, design, CQV and close-out.
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Assist in cultivating a good Food Safety Culture within the organization by ensuring that compliance to SQF, GMP, HACCP and FSMA standards is being maintained on the manufacturing and warehouse floor.
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Basic Qualifications Requires 3-5 years with a BS degree in a related scientific discipline ( chemistry, biology) or equivalent combination of education and previous relevant experience in the pharmaceutical industry, related GMP environment, or equivalent.
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Experience on automation validation (DeltaV, MES, PI) in GMP environment that includes test script generation and execution. The Lead automation engineer will be responsible to support the operations on all GMP manufacturing systems (Process Automation System) in the Manufacturing Facilities in Devens, MA.
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Responsible to ensure HACCP, GMP, Safety, OSHA, SOP’s and all quality programs are being followed. We are is partnering with a leading bottling company in its search for an experienced Quality Manager for their Ayer, MA facility.
$90,000 - $110,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ensure GMP processes are implemented in the Quality Management System (QMS) for clinical and commercial product process lifecycle (e.g. control strategy, technology transfer, process validation lifecycle, continuous process verification.
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The employee will on occasions be required to enter the warehouse, lab, and/or production environment requiring the use of personal protective equipment such as safety glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines.
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Must have experience on all general housekeeping tasks-REQUIRES OPERATING A WALK BEHIND AUTO SCRUBBER AND WAREHOUSE CLEANING AS WELL AS GENERAL HOUSEKEEPING RESPONSIBILITIES.-GMP cleaning including documentation of tasks and daily floor sanitation- Floor Care, Buffing, Auto Scrubbing, Carpet Cleaning, Floor Scrub and Finish.
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Qualifications Strong Knowledge of SMT Processes, equipment, and industry best practices Working knowledge of basic printed circuit board design and concepts Working Knowledge of GMP and ISO requirements.
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These areas may include, but are not limited to Shipping and Receiving, GMP Raw Materials, and InventoryControl. Performing daily GMP material receipts according to SOPS/WI and Materials Specifications.
$32 an hourTemporaryExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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5-10 years' experience in maintenance planning, scheduling and/or MRO inventory management in a GmP environment. GMP (5 years of experience is required) Prior experience with systems such as Allen Bradley , Siemens, Modicon and Wonderware a plus.
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Applies advanced working knowledge and experience to independently improve maintenance techniques and operations in a highly regulated GMP environment under the guidance and direction of the Maintenance & Facilities Manager.
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Biopharmaceutical GLP or GMP lab environment). BS with minimum of 3-4 years of experience in a GMP QC lab is required (or equivalent experience in a related. biopharmaceutical GLP or GMP lab environment.
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Education & Experience: 0-2 years of work experience in Quality Assurance/Control/Microbiology in a GMP environment. Conducting quality audits of the manufacturing process, including GMP and hygiene monitoring.
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gmp job Company: Genoskin in Acton, MA
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