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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). Associate Director-Quality Assurance (QCMC) Company is seeking a highly experienced, motivated, and innovative quality leader with strong experience in early and late-stage development to join our Quality team as Associate Director, Quality Assurance to support drug development from Phase 1 to late-stage development.
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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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Ideal candidate will have extensive CMC (Organic and/or Analytical chemistry) experience with at least 10 years in CMC-QA leadership roles. 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.
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Key Responsibilities Provide quality leadership, strategy, and compliance oversight to CDMOs, CMO, CRO, CPO, Third Party Vendors. Assist in the development, approval, maintenance, review, management of agreements (such as QAA, MSD, consulting agreements etc.
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Ensure that CMC quality systems, validation, product specifications, product release, reference standard and stability programs are phase appropriate, effective, meet standards expected by US and global regulatory authorities.
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Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
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Quality Assurance AssociateSummary:Safe Horizon’s Family Focused Program provides comprehensive trauma-informed client-centered services to families who are affected by intimate partner violence and are involved in the child welfare system.
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Qualifications: Bachelor's degree required NYS Clinical Laboratory Technologist license or Histotechnologist license is required In-depth knowledge of laboratory procedures, regulations, and quality assurance Join our clients team as a Laboratory Supervisor and make a significant impact on high-quality patient care through effective management and supervision.
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This position is under the direction of the Principal Investigator(s), Data and Operations Management Center (DOMC) Director and other leadership, the Temporary Research Assistant is responsible for data collection, quality assurance of collected data (clinical, laboratory, demographic), regulatory submissions, routine data management tasks for data transmitted from the international sites, manuscript development, proposal assistance and other relevant scientific activities.
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Provide ongoing quality assurance regarding Care Management outreach and engagement. Perform quarterly Quality Assurance/Quality Improvement duties. The Licensed Clinical Social Worker (LCSW) Supervisor will provide comprehensive leadership and supervision to the LMSW and SW Interns in our Primary Care Department.
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Assisting the Program Director in daily operations of quality assurance services provided to agency program teams, including but not limited to, internal reviews, monthly reporting, monthly and quarterly committee meetings and other activities as assigned.
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Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods. The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing.
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Liaise with US and foreign regulators externally and Citi Internal Audit and Compliance Assurance staff, as appropriate, including coordinating AML-related examinations, audit and reviews, document production, and issue responses to confirm there is consistency in responses and issues are communicated across regions, such that actions and conclusions are shared.
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We solve customers’ most challenging regulatory compliance, audit, and risk management requirements to provide customers with the confidence to operate their most sensitive workloads securely on AWS. We are looking for an independent, passionate, and deeply experienced leader with experience and expertise in developing and implementing compliance and assurance programs in global environments.
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Manage the Quality Assurance/Quality Control (QA/QC) program. Manage project superintendent, assistant project manager and project engineer. Proficient in Procore and take the lead in the administration of same for specific project.
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assurance job Company: Google in New York, NY
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