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The Senior Specialist, External Manufacturing Quality plays a crucial role in upholding compliance with Quality Systems governing externally manufactured products and processes across their entire lifecycle within the Rx, OTC, Cosmetic, and Medical Device regulated environment.
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10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC. Hands-on experience with designing and implementing GMP Quality Systems.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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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. A background of pharmaceutical manufacturing or quality control/quality assurance is a plus.
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As a Cultivation Specialist you are responsible for maintaining quality control measures and ensuring the health and safety of crop during the life stages of the plant, from propagation to pre-harvest.
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JESCO is a premier dealer of heavy construction equipment and technology in the Northeast and Mid-Atlantic regions.
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Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches. This individual will be responsible for Quality oversight and support of cell therapy manufacturing operations, in full compliance with established cGMP requirements.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Additional relevant certifications such as Certified Information Systems Security Professional (CISSP), Certified Cloud Security Professional (CCSP), or Certified Kubernetes Security Specialist (CKS.
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The Desktop Support Specialist provides a higher level of technical support through analysis and problem solving to facilitate installation, implementation, maintenance, education, and documentation of a variety of computer and software technologies.
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Job Title: Lead - Quality Assurance. Gather application's business requirements and specifications for developing architecture pattern, formulating test plan & strategies, test analysis, test design, test cases, development & maintenance of database using Azure DevOps, IBM Rational and Collibra Data Governance center, SharePoint, Data Modeling, & Oracle SQL Developer.
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In person or Remote (East Coast with initial training onsite at Bridgewater, NJ and few days for the first few months)DutiesThe CMC Regulatory Technical Writer II authors high quality Module and regulatory submissions for both development and post-approval dossiers, change controls and technical reports.
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Work From Home, Entry Level Data Entry Clerk As A Research Participant
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COMPANY MISSION: To live our four core values of: Building Leaders, Always Branding, Listen, Fulfill, and Delight, and Creating a Fun Enthusiastic Team Environment.
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The Senior Specialist, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. Experience interacting with CROs. Performing TMF QC for Contract Research Organization (CRO) TMF and ensuring quality of the TMF.
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Knowledge of quality systems (GxP, ISO, Lean, TPS, etc.) Then consider joining us as a Quality and Safety Manager in Piscataway, New Jersey! You will be responsible for the overall quality and safety for the full environment of our new distribution center.
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3-5 years of experience in drug safety, pharmacovigilance, quality assurance, or a related field. Provide drug safety and pharmacovigilance leadership to the quality and compliance team, fostering a culture of collaboration, excellence, and continuous learning.
Full-timeRemoteExpandApply NowActive JobUpdated Today
Title: quality specialist Company: Direct Line Global in Somerset, NJ
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