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The Scientist, Analytical Development & Quality Control is responsible for analytical development, feasibility, method qualification, routine, and stability testing of antibody drug conjugates and intermediates.
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Interact with internal cross-functional teams, including Analytical Development, CMC, Supply Management, Regulatory Affairs, Program Management and Quality Assurance, as well as with Alpine's/Vertex network of external CMOs/contract labs to support company's clinical programs.
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If you are interested or know of someone that would be a great match, please send a MS Word resume to John Marino at John@SourceRecruitmentSolutions.com Source Recruitment Solutions, LLC. Or apply now online by directly clicking the “ APPLY NOW ” link: #Quality #QualityAssurance #QualityAssuranceManager #QualityAssuranceJobs #food #HACCP #SQF #ConsumerProducts #Monster.com.
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Ensoma is seeking an experienced GMP Quality Assurance professional to use your resourceful and innovative thinking for a highly visible role within our rapidly growing company. Help to build the internal quality management system, including the development of vendor management and batch disposition processes.
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Reporting to the COO, The Vice President, GxP Quality Assurance is responsible for establishing and leading Aveo’s Quality Management System (QMS) operations and ensuring compliance with Local, State, Federal, and International regulations and standards associated with GXPs and Quality Systems in a fast-paced, primarily virtual development environment.
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Responsible for Quality & Controls Assurance programs, activities and reviews, including claims reviews; call center and digital communications reviews; Medicare Risk Adjustment, HCC, clinical and coding reviews; DRG and medical records reviews; technology/systems and coding upgrade and implementation reviews (e.g. final user acceptance testing, etc.
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Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry or related field) and 6-8+ years of analytical development & quality control experience with complex biologics, particularly Fc-fusion proteins and monoclonal antibodies from early to late-stage development (or equivalent combination of education and experience.
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Job DescriptionDirector, R&D Quality, GCP - Cell Gene Therapy (CGT)The Director of R&D Quality, GCP - Cell Gene Therapy (CGT) reports directly to the Head of RDQA and is a trusted advisor and partner to clinical and quality stakeholders and business partners and supports the program and study level quality leads in key quality related clinical activities and deliverables for all CGT programs across the Vertex clinical portfolio.
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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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Reporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen’s pipeline.
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Title QUALITY ASSURANCE OFFICER $20 - $22 About the Organization New England Security is a full-service security company specializing in armed and unarmed security guard patrol services, private investigations and corporate security services, with the professional experience and resources to provide superior protection to our clients.
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Lead quality improvement initiatives using Six Sigma, Lean, and other methodologies. 5+ years of quality management experience in the semiconductor industry. Oversee quality assurance processes, including product inspection and testing.
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Ensure the effective execution of quality control procedures throughout the entire product lifecycle (design, development, manufacturing, distribution, post-market surveillance) Oversee the implementation of Supplier Corrective Action (SCA), complaints, corrective and preventive action (CAPA) processes, and Non Conformance Reports Develop and maintain a strong quality culture within the organization, fostering employee ownership and commitment to quality.
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Support the development and maintenance of company Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate. The role of Manager, Clinical Quality Assurance, supports Quality oversight for Bicycle’s development programs, ensuring compliance with applicable GLP and GCP standards and global regulations.
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Providing Quality Assurance support to bluebird bio’s CMC and Tech Transfer teams. Providing Quality representation on internal bbb and external CMO/CLO cross functional teams for development, method transfer, and assay validation projects.
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Title: quality Company: Waukegan Hospital in Newton, MA
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