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Analyze collected data and coordinate corrective action plans and quality improvement activities. Experience in apheresis, cell therapy/stem cell transplantation, bone marrow transplant, hem/onc, laboratory medicine, and/or regulatory compliance/quality assurance preferred.
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3+ years of experience in a Quality Assurance/Quality Operations Manager role in Pharma industry. Job Description PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management.
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Experience in a biotechnology or pharmaceutical company, with 10+ years of direct involvement in analytical development and/or quality control of protein biologics. This individual will be responsible for overseeing key deliverables in analytical development such as method development, assay qualification, release/stability, in-process assays, in-use stability methods, quality control, and quality assurance aspects of Spyre’s pre-clinical & clinical biologics product candidates while partnering with other Tech Ops development groups and quality assurance.
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Conducts audits to ensure the quality management system is operating effectively; collects required data for audits directly, when possible, analyzes collected data, and coordinates multidisciplinary corrective action plans and quality improvement activities, serving as a close liaison with the BTS.
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The Manager is a hands-on manager that can organize and lead a team of QC personnel, support and execute QC testing, and contribute significantly to overall Quality Control strategy The ideal candidate will have experience working in a GMP QC laboratory setting, experience with cell and gene therapy test methodologies, compendial safety testing and enjoy a fast-paced, collaborative, and vibrant startup culture.
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The QA Test Manager plays a critical role in ensuring the quality and compliance of the software solution with the client's functional and technical requirements. The QA Test Manager will manage and participate in the creation of complex test scenarios & data sets, conduct workflow analysis, and maintain comprehensive test assets, including test scripts, results, and defects.
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The incumbent will work cross-functionally with colleagues from Manufacturing, Manufacturing Science and Technology, Global Engineering, Validation, Process Engineering, EM/UM Quality Control, CMC Regulatory, and Quality Operations on the design of processes and technologies required to produce aseptic drug product to successfully commercialize an exciting and diverse portfolio of innovative cell and gene therapy pipeline programs.
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As an Indirect Tax Manager within the Multistate Tax Services group, you will provide state and local indirect tax planning, consulting, and compliance services to a diverse client base in various industry sectors.
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Position Summary: As Wholesale Manager, your primary focus will be on achieving order distribution and quality control objectives. Awareness of, understanding of, and implementation of all NAC and NRA pertaining to the inventory, distribution, and quality control of cannabis from seed to sale.
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The relevant infrastructure will include elements such as an enterprise data catalog, data governance (including conventions and standards), data quality, master data management, application integration, data exchange, ETL/ELT, data modeling, and related components.
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The Associate Director, Lab Operations Quality Assurance, will work as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications.
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The Practice Manager collaborates closely with Radiology Director to ensure consistent, quality care to all patients. The Practice Manager collaborates closely with QA Management, Leadership, Safety, MGB shared services such as MGH Speech, Radiology information services, Anesthesia and Surgery to ensure consistent, quality care to all patients across all modalities.
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The Head of R&D Automation platform is responsible for leading the technical design, implementation, testing and deployment of automated processes to accelerate Takeda's portfolio starting with preclinical research and ending with submission with the objective to improve efficiency and data quality across the entire business and data flow.
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Provide quality guidance on process qualification, and continuous process verification strategies for gene editing components (i.e., oligonucleotide guide, CRISPR endonuclease, and ribonucleoprotein [RNP] complex) and ex vivo CRISPR gene-edited cell therapies manufactured internally and at CMOs.
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In this position, you will be responsible for driving the development of optimal CMC regulatory strategies and the preparation and submission of high-quality CMC sections of INDs, IMPDs, CTAs, and original marketing applications (NDAs/BLAs/MAAs), in close collaboration with our in-house CMC and Quality teams, contract manufacturing organizations, external experts, collaborators, strategic partners, and health authorities.
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quality job Title: data manager Company: Deloitte in Boston, MA
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