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Oversee cGMP contract testing, including review and approval of analytical methods, method validations, specifications, qualification, and stability programs at CROs and CMOs. Ensure Quality Control related documentation (QC test methods, analytical validation and/or qualification, reference standard program, and stability studies) meet ICH [International Conference on Harmonization] and other regulatory guidelines.
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Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system. Perform review of release, stability, validation, analytical quality control tests on raw materials, in-processing and final products.
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The QC Lab Manager (Shift) will be responsible for overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta's Gene Therapy pipeline.
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Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Control Analyst I, that will be primarily focused on wet chemistry, based onsite in our Andover, MA facility. The Quality Control Analyst I (RP/ISO) is responsible for conducting routine analysis of materials including: Raw materials, in-process and finished formulations under general supervision and in accordance with standard operating procedures (SOPs.
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Serve as a leader within the QC group and as a knowledge resource (data review, electronic review, data integrity, GDP) within the company. Plan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activities.
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As a Project Quality Control Manager, you will play a critical role in the overall leadership and successful and timely delivery of complex multimillion-dollar fast-track, complex heavy-civil, highway and bridge projects from pre-construction stage through project execution and completion.
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Author and review quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites. This individual will support method development, validation, and quality control activities conducted at Sarepta Andover in compliance with cGMP regulations.
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Experience with the use of quality systems and tools (for example, CAPA, Six Sigma methodology, change control, Statistical Analysis, Control Plans, and document management) Manager, Quality Systems Engineering - Medical Products page is loaded.
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Uses Microsoft Excel to monitor release dates, and position to program need on WIP. Works with Manufacturing Supervisor, Manufacturing Engineer, Quality Engineer, Program Manager, etc. Prepare assembly kits for issue to the manufacturing floor in a manner which meets established standards of quality and schedule.
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The Senior Analyst / Scientist will work cross-functionally with others in Quality Control, Analytical Development teams, Quality Assurance, and Manufacturing, as needed. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs) and analytical assays for AAV efficacy (potency), safety and product quality.
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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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Job Title: Quality Systems Engineering Manager. Quality certifications like ASQ Six Sigma Green Belt or Black Belt, CQE, etc. Excellent knowledge of Quality Management System (QMS) in high volume semiconductor, or electronics manufacturing environment.
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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 is a highly impactful role requiring a seasoned professional equipped with a keen understanding of supply chain management, quality control, and food safety standards. Enforcing strict compliance with safety (HACCP, OSHA), personnel, security, pest control, and shrink control policies.
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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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quality control qc manager jobs Title: project manager group in Billerica, MA
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