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Ideal candidate will have extensive CMC (Organic and/or Analytical chemistry) experience with at least 10 years in CMC-QA leadership roles. ·Performs assessments and QA review of source documents, change controls, deviations, quality events, CAPA, root cause analysis, product impact assessment, investigations, including OOS investigations and other reports for accuracy.
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Basic Qualifications: B.S. Biological Sciences, Chemistry or relevant discipline and a minimum of 10 or more years’ related experience in the pharmaceutical/biotechnology industry with increasing responsibility and relevant QA experience or an equivalent combination of education.
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Develop and manage a risk-based Quality Management System for QA in compliance with applicable regulatory requirements (US) and company policies. Performs disposition activities for manufactured products in support of clinical products, including MBR, EBR review, and approval and review of CoA. Responsible for Management and maintenance of the Veeva Quality Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal quality documents (SOPs, Wis, Policies, Forms, etc.
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This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company’s clinical and commercial products follow cGMP framework and guidelines. The Associate Director, Quality Assurance will be based in our Northern New Jersey, offices 1 - 2 days a week (flexible schedule for the ideal candidate.
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Maintain Department sanitation and QA standards, including sweeping, mopping, removing cardboard and refuse as needed,Operate a baler or compactor. Perform duties in accordance with QA hand washing standards and use disposable gloves when handling food.
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Supervise and develop the QA team, including the QA Supervisor, Technician, and Engineer. The role involves overseeing QA programs, ensuring ISO and regulatory compliance, and utilizing tools such as auditing, process evaluation, and trend analysis to achieve business objectives.
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Collaborate on product direction: You will build solutions that surprise and delight our internal customers in a range of disciplines - Software, Product, User Experience, QA. - Lead beyond your team: You will be a key part of a small but growing community of senior engineering leaders.
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ADDENDUM FOR QUALITY AUDIT MEASUREMENT TEAM ANALYSTS:Identifies process improvement opportunities for platform work as an example, review SQM and QA reports, review trends to identify process improvement and automation)Gather, process FCR and QA performance data and conduct trending and root cause analysesDesign and develop standard reports for metrics reporting and analysis.
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Document QA test plans and execute test cases. The ideal candidate should have broad knowledge and understanding of various instrument asset classes like Fixed Income, Equity, Funds, FX, Derivatives such as IR Swaps and pricing data.
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Perform team-lead/QC duties with the client around performance, production, and quality goals and metricsQualifications/ Requirements:College degree / training in Finance / mortgage banking desired, or equivalent combination of education and experienceMinimum of 6+ years of industry and/or relevant experience, typically with 1+ years in a Senior Associate level role or external equivalent.
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Performs visual, and documents, QA/QC and preventive maintenance checks, records and reports results to appropriate personnel. NYS X-Ray License and Certified by the ARRT. Minimum of 2 years experience in a radiological environment.
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A deep understanding of the strategic and executional aspects of managing direct partnerships, including vendor RFPs/evaluation/negotiation, in-platform plan setup, contracting, creating trafficking requests, post-launch QA, reporting, etc.
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Support the transition of legacy on-prem applications to cloud applicationsPerform application integration, configuration and packaging requirementsActs as the subject matter expert for enterprise applications to ensure ease of use and full leverage of the toolsDefine and maintain firm standards for implementing softwarePerform QA testing of new application installs and upgradesWhat skills and experience are we looking for in a Legal Application Engineer.
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The HORIBA Group of worldwide companies provides an extensive array of instruments and systems for applications ranging from automotive R&D, process and environmental monitoring, in-vitro medical diagnostics, semiconductor manufacturing and metrology, to a broad range of scientific R&D and QC measurements.
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Author, review, and approve SOPs, protocols, reports, change controls, Trackwise deviations, out-of-specification (OOS) and out-of-trend (OOT) investigations, and CAPAs for the QC Bioassay/Virology team, as needed.
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qa qc jobs Title: cytogenetic in New York, NY
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