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The Clinical Systems Analyst will assist the Senior Director of Clinical and Development Systems in planning, directing, and coordinating software projects and support activities within the Drug Safety, Pharmacovigilance, Regulatory, Clinical Operations, and Quality Assurance groups.
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3-5 years of experience in drug safety, pharmacovigilance, quality assurance, or a related field. This role requires a strong leader with a deep understanding of commercial patient services, pharmacovigilance, quality assurance, and regulatory compliance.
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A background of pharmaceutical manufacturing or quality control/quality assurance is a plus. The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports.
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Experience in Quality Assurance/ Quality Systems related to cell therapy manufacturing in commercial setting. Minimum 4 years of relevant work experience with Quality Assurance Systems or Quality Assurance Investigations.
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Global Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expandingLooking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization.
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Johnson & Johnson is currently recruiting for a Lead, Infrastructure Assurance to be locatedin Raritan, NJ. At Johnson & Johnson, we believe health is everything. Knowledge or certifications in Software Quality Assurance and Software Quality Engineering.
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In addition, this role will perform critical quality assurance activities such as Change Management, SOP Management, and Audit oversight. Experience with Veeva (Quality Docs, QMS and Training modules) a plus.
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Intermediate knowledge of Microsoft Word, Microsoft Excel and Adobe AcrobatKnowledge of cGMP/GDP regulations, ICH Guidelines, and CMC (Chemistry and Manufacturing Controls) recommendedExcellent communication, organizational, interpersonal and computer skillsExcellent Oral/Written Communication SkillsDemonstrated ability to manage multiple competing prioritiesSolid organizational skills and attention to detail.
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Create, route and track controlled records within documents management system, Veeva. This includes documentation control, change control, deviation management, and CAPA (Corrective and Preventive Action) systems.
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Position requires on-site presence at companies' HQ Essential Duties and Responsibilities Conducting Training: Developing and conducting training programs for personnel on GMP and GDP requirements, quality systems, and relevant procedures to ensure understanding and compliance throughout the organization.
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Developing and Maintaining Quality Systems: Establishing and maintaining comprehensive quality systems in compliance with GMP and GDP regulations. Sets and manages audit schedule – collaborating with Tech Ops and internal QA to ensure audit reporting reflects current state of compliance at COs and to help address issues requiring remediation.
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Manage offsite storage for all documents for the Bridgewater office, including detailed inventory and data entry into IM Connect for tracking purposes. Continuous Improvement Initiatives: Leading or participating in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes, driving a culture of quality and excellence within the organization.
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Performs quality assurance testing, and acquires and records all parameters needed to deliver radiation therapy accurately, using policies, practice standards, prescriptions and professional judgment to ensure quality with regard to all aspects of treatment delivery.
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Productive experience with software testing, quality assurance (QA), and compliance requirements. For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
$90,000 - $144,900 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Senior Manager also develops and establishes Quality Assurance testing methods with IT Operations, including automated regression test methods and tools using the golden dataset concept. Licenses & CertificationsSAP S/4 HANA The Open Group – TOGAF Software/Technical SkillsEnterprise Architecture Design toolsSAP S/4 HANA – specifically, P2P, OTC, FP&A, S&OP, IBP (must be proficient in at least three process domains)(CRM) Customer Relationship Management Integration(LES) Logistics Execution System IntegrationJira Issue & Project Tracking Software Other Skills, Knowledge, & AbilitiesBusiness Analysis.
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assurance job Company: Johnson in Branchburg, NJ
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