• Catalent (Manassas, VA)
    …of customer orders across functions with guidance from the Customer Service Manager . The Customer Service Representative is responsible for building and maintaining ... our customersGeneral knowledge and understanding of customer contracts (Supply Agreement/ Quality Agreement) including but not limited to firm-zones; purchase order… more
    HireLifeScience (02/07/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …and management of clinical trial management systems and archiving systems . Relationships Reports to a Manager (or above) within NACD. Manages mutually ... all relevant services/tasks in support of the planning and quality delivery of clinical trials in line... clinical trials, including distribution of SUSARs to clinical trial sites Maintenance of systems , eg,… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Rahway, NJ)
    …training materials- Prepare clinical narratives- Collaborate cross-functionally to monitor clinical study data to ensure quality , completeness, and integrity ... and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your...will partner with CSSM team members to train on systems and tools to complete tasks and deliverables critical… more
    HireLifeScience (02/28/24)
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  • Catalent (San Diego, CA)
    …Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of...experience in QA/Regulatory Affairs areas with progressive responsibilities for quality metrics, quality systems , deviations,… more
    HireLifeScience (02/14/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionThe Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval of documentation ... to support Good Manufacturing Practice (GMP) - clinical supply API manufacture, testing, release, and maintenance in support of our company's clinical supply… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    Job Description- The Rahway based Specialist, Global Development Quality Operations - API,- is responsible for review and approval of documentation to support Good ... Manufacturing Practice (GMP) clinical supply API manufacture, testing, release and maintenance in...audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard… more
    HireLifeScience (03/23/24)
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  • Catalent (St. Petersburg, FL)
    …responsibility for Quality aspects including but not limited to Quality Systems , Finished Product Batch Release, Training, Internal/External Audits, ... safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality...of bachelor's degree, a minimum of 5 years of Quality or IT role supporting GxP systems more
    HireLifeScience (02/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …[QMS] QA, PV/MA Quality ) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ensure ... in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD business process owners that… more
    HireLifeScience (02/24/24)
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  • Eisai, Inc (Nutley, NJ)
    …Plan and monitors study conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study Report - provides statistical and ... want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work...across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development,… more
    HireLifeScience (02/03/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager of Supply Chain and Logistics plays a crucial role in supporting ... both the commercial and clinical supply chains at Insmed. The primary focus is...management of shipments, ensuring timely and accurate deliveries.Implement tracking systems to monitor the progress of shipments and address… more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …that seeks to constantly enhance global regulatory compliance for aggregate reports.Develops quality systems , tools, and procedures for the aggregate report ... reporting (AR) for investigational and post-marketed medicinal products within the Clinical Safety and Pharmacovigilance (CSPV) department. Since a global vendor has… more
    HireLifeScience (03/15/24)
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  • Catalent (St. Petersburg, FL)
    …productionProvide support to internal, client, and regulatory audits.Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at ... for their clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval… more
    HireLifeScience (02/23/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Sr. Manager of Operations - Continuous Improvement and Projects as part of the ... be responsible for providing operational excellence leadership to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
    HireLifeScience (02/16/24)
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  • 4S (Silver Spring, MD)
    …applying data mining techniques, doing statistical analysis, and building high quality prediction systems integrated with our products. Demonstrate understanding ... reports writers, under the supervision of the Data Architect and Project Manager . Essential Duties and Responsibilities: (Not listed in order of importance; other… more
    JobGet (03/10/24)
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  • Merck & Co. (Rahway, NJ)
    …interpersonal and conflict resolution, and oral/written communication skills.Strong background in Quality Systems , with ability to develop/manage a suite of ... improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure.- The Automation Leader plays a key role… more
    HireLifeScience (03/26/24)
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  • Behavorial Health Network, Inc (Springfield, MA)
    If you are a Clinical Manager or experienced Independently Licensed Clinician looking to advance in your career, mentor others to help improve our community, ... our team of competent and compassionate professionals as a Clinical Manager in CBHC Outpatient Services at...employment. This includes professional goal setting and progress, high quality clinical service delivery, and compliance with… more
    JobGet (03/25/24)
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  • Novo Nordisk Inc. (New York, NY)
    …the system population. Internally, the Diabetes Educator reports to the Health Systems Diabetes Educator Manager (HSDEM). The Diabetes Educator primarily aligns ... for the "at risk" diabetes patient population (Eg, providers, care coordinators, quality , population health, clinical pharmacy) Educate providers on strategies… more
    HireLifeScience (03/26/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …driving compliance. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties will be assigned, as ... clinical manufacture or NPI is preferred. Experience in clinical quality , method development, cell banking, or...& Development is preferred. Proficient in the use of quality systems such as SAP. Experience working… more
    HireLifeScience (03/13/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …to help the team, in a manner consistent with safety policies, quality systems , and cGMP requirements. Support manufacturing investigations, create/revise ... directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be… more
    HireLifeScience (02/27/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager when data discrepancies ... seeking a QC Data Reviewer as part of the Quality team based in Raritan, NJ. Role Overview The...related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP… more
    HireLifeScience (01/03/24)
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