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As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy operations in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
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We are seeking a highly organized and experienced Quality Assurance (QA) Manager with strong people management skills to lead our Boston team and ensure overall GxP compliance. Strong working knowledge in all or an area of FDA and EPA Good Laboratory Practice (GLP) regulations, Organization for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice, FDA Good Clinical Practice (GCP) regulations, Good Clinical Laboratory Practice (GCLP) principles, and/or FDA Good Manufacturing Practice (GMP) and industry standards as they apply to the life sciences and pharmaceutical industries.
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Experience in Life Sciences practices: Clinical Operations, Regulatory Affairs, Quality, Pharmacovigilance, Data Science, Commercial, Manufacturing, Supply Chain, Medical Devices. Experience with GxP guidelines, Software Development Life Cycle (SDLC) process, Computer System Validation (CSV)/Computer Software Assurance (CSA.
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This entry-level position reports to the Manager Vivarium Solutions, and is responsible for the daily care of research animals, including feeding, watering, cage changing, maintaining a clean work environment, and monitoring the overall health of the animals.
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We are working with a client this is looking for a qualified Quality Assurance Manager to join their team with comprehensive knowledge of manufacturing processes and ISO9001 Our client builds the world’s most powerful, combat systems for survivable naval ships and defense technology solutions that safeguard our warfighter on seas, sky, land, space & cyber.
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DataCon one of the US leading SDVOSB defense contractors is hiring a Quality Assurance Manager for our US Navy business in Chelmsford, Mass. The Manager of Quality will develop and oversee quality management.
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Belonging to the Project Services/EngineeringManagement (EM) team and reporting to the Senior Engineering Manager orProject Services Director, the individual is responsible to manage thedesign process of an offshore wind project from origination throughfeasibility, concept, FEED (Front End Engineering Design), detaildesign, procurement, manufacturing, installation, commissioning, andhandover to operations.
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The Audit Manager will perform and direct a broad range of accounting tasks and will assist the audit team in the development of audit strategy, planning, review and interpretation of audit findings for clients within various commercial industries such as architecture and engineering, manufacturing and distribution, retail and consumer products, technology and more.
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At least 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity including at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
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The Quality Assurance Manager, CMC, has responsibility for the overall management of batch record review and lot release. This includes, but is not limited to, raw materials, vector, supplier quality, audits and inspections, training, quality systems, quality operations, quality control, contract testing labs, and contract manufacturing organizations.
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Preferred Qualifications: · Master's degree in Accounting or Finance· CPA or CMA certification· Strong understanding of Federal Acquisition Regulations (FAR) and Cost Accounting Standards (CAS) Previous Audit/Assurance experience.
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Cross-Functional Collaboration: Collaborate with cross-functional teams, including Clinical Development, Nonclinical Development, Quality Assurance, Analytical Development, Manufacturing, and Legal, to provide regulatory guidance and support for product development, manufacturing, and commercialization activities.
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We focus on a collection of organizational technology capabilities, including business intelligence, data management, and data assurance that help our clients drive innovation, growth, and change within their organizations in order to keep up with the changing nature of customers and technology.
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The Manager/Senior Manager of Quality Assurance provides oversight of GMP activities and the supports disposition of clinical supplies. Provides direct Quality Assurance oversight and support for the assigned area (e.g. external manufacturing, quality control and product development.
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For Sr. Manager 8+, Associate Director 10+ years of experience in regulated pharmaceutical manufacturing with significant GMP/CMC QA experience. Director GMP Quality Assurance will collaborate with the CMC department and external Vendors to ensure oversight and compliance.
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assurance manager manufacturing jobs in Quincy, MA
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