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Reporting to the Director, QC Molecular Biology, the Analyst I - QC Molecular Biology will support the gene therapy program pipeline including but not limited to routine GMP testing of AAV vector analytical methods such as GC titer determination by ddPCR and qPCR, impurity testing, and other methods as needed.
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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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Filling, Gmp, Sop, Inventory Control, Six Sigma, pipetting, Reagent, biotechnology, microbiology, microbiologist. GMP and SOP procedures. Filling, Gmp, Sop, Inventory Control, Six Sigma, pipetting, Reagent, biotechnology, microbiology, microbiologist.
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Strong computer skills in Microsoft Office required, especially MS Word, MS ExcelNice-to-HaveBachelor's DegreeKnowledge of fermentation and or downstream processing techniquesPrior experience in a GMP or GLP environment.
$23.28 - $38.8 an hourFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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1 - 3 years GMP/GLP experience. Electro-Mechanical assembly skills. The Electronics Assembly Technician I is a non-exempt position that reports to the Electronics Management Team. The Electronics Assembly Technician I is responsible for assembling and testing full assembly and individual sub assembly parts for Charm Sciences equipment.
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Aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards) Identify and communicate risks and gaps in quality and GMP systems, contributing to continuous improvement efforts within the manufacturing environment.
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Quality Assurance experience & knowledge of GMP required. Knowledge of Lean, Kaizen, and Continuous Improvement initiatives. Abiomed, part of Johnson & Johnson MedTech is recruiting for a Production Supervisor, 2 nd shift located in Danvers, MA.
Full-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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The Complaint and Training Coordinator plays an integral role in ensuring that the company is compliant with complaint handling documentation and reporting activities as well as training documentation activities relative to the company’s GMP system.
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Experience working in a SOX/GMP Validated environment a strong plus. SOX/GMP Validated environment: 3 years (Required) Ensure functional work activities are conducted in compliance with technology and GMP requirements, related policies and procedures, and corporate objectives.
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Identify risks and communicate gaps for quality and GMP process/systems. Randstad in partnership with one of the largest pharmaceutical companies in the worldis seeking a Specialist/Senior Specialist to support Quality On The Floor (OTF) oversight of manufacturing activities and Facilities at Moderna Inc. This position will be based in our cGMP Manufacturing site in Burlington, MA and will directly support the growing Personalized Medicine Program.
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This training is designed for medical device compliance and you will be trained on GDP and GMP standards. This includes eLearning, reading, quizzes, etc. Local to Billerica, MA with the availability for a full time, second shift role and ability to travel to and from the location.
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Primary Responsibilities:Provide technical leadership and subject matter expertise to the Nucleic Acids testing team to ensure the successful execution of all GMP release and stability PCR testing executed in support of Sarepta’ s Gene Therapy programs (currently 1 commercial program and 5+ active clinical programs.
$156,000 - $195,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Document work as required for GMP compliance. Perform routine testing of pharmaceutical samples by following analytical compendial methods (pH, osmolality, concentration, break-loose extrusion force, etc.
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Maintain GMP cold chain equipment in a constant state of organization and GMP compliance - includes changing charts and liquid nitrogen tanks. Supply and transfer GMP Raw Materials and General Supplies in support of Manufacturing Operations at the Cambridge and Lexington facilities.
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We are seeking a highly skilled and detail-oriented GMP Test Technician to join our team. The GMP Test Technician will play a crucial role in maintaining the highest standards of quality assurance in a regulated manufacturing environment.
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gmp job Company: Genoskin in North Reading, MA
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