- Daiichi Sankyo, Inc. (Bernards, NJ)
- …HRMS applications, possessing deep understanding of HR business processes, and business systems requirements . Accountable for global systems implementations ... technologies, ensuring a focus on an outstanding end-user experience.Responsibilities- HR Systems ManagementAct as the principal functional expert and advisor for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …ready state.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements .RequirementsA minimum of a Bachelor's Degree in ... observation resolution.Drive site compliance to regulatory, enterprise, and global requirements through building positive relationships across functions, to meet… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of testing.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements .Other duties will be assigned, as necessary. ... SOP's and WI's.Ensure microbiological control strategy is consistent with cGMP requirements .Participate in training and delivery of Operations aseptic technique and… more
- Merck & Co. (Rahway, NJ)
- …Scientist with a strong interest to develop quantitative models of biological systems .- The successful candidate is eager to learn and excited to overcome ... company's laboratories.Responsibilities include but are not limited to:Develop a quantitative systems pharmacology (QSP) model of key pathways regulating body weight… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …role in the design, implementation, and optimization of automated building control systems , especially HVAC system automation, with a strong emphasis on the Tridium ... The successful candidate will have strong experience with building and HVAC automation systems , a deep understanding of Tridium Niagara N4, and a commitment to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tasks in a manner consistent with the safety policies, quality systems and cGMP requirements .Critically support investigations and reports, interpret ... processing is a plus.Ability to identify/remediate gaps in processes or systems .Experience with cell and/or gene therapy analytical technique (eg flowcytometry,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the sitePerform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements .Require minimal direction to complete tasks, knows ... processing is a plus.Ability to identify/remediate gaps in processes or systems .Experience reviewing/auditing GMP documentation including but not limited to: SOPs,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and WI's.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements .Job duties performed routinely require exposure to ... the QC laboratories.Perform peer review/approval of laboratory data. Utilize electronic systems (LIMS) for execution and documentation of testing.Create, review and… more
- Aequor (Vacaville, CA)
- …8AM - 5PM) Job Description: We are seeking a highly motivated and experienced Quality Systems Support Specialist to join our team in Vacaville, CA. In this role, you ... control and PQS integration, ensuring compliance with cGMP and global requirements . Key Responsibilities: Support the implementation, execution and maintenance of… more
- Merck & Co. (Durham, NC)
- …work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model ... applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …records, collaborating with Compliance for impact assessments on new reporting requirements HCP Engagement Systems Development: Assist in developing and ... partners to enhance system performance, ensuring compliance with reporting requirements , and identifying opportunities to improve the accuracy and timeliness… more
- BAXTER (Medina, NY)
- …device/pharmaceutical company or similar regulated industry, preferred.Working knowledge of Quality Systems and related requirements and standards, including 21 ... Medina Design Center) CAPA Review Board. Maintain CRB information per established requirements , as needed.Develop and provide training as needed. Assist with Quality… more
- NetApp (San Jose, CA)
- …from design to Cloud deployment. Key ResponsibilitiesTranslate complex product requirements into leading-edge Kubernetes-based customer solutions using Golang and ... Python.You'll build quality into your code through unit and integration test development and continuous DevOps pipelines.Provide team and project technical leadership, mentor other engineers and participate in technical decisions.Work on additional tasks and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the following is desired: Microsoft Windows Operating Systems and Networking systems (Ethernet) FDA and EMEA Regulatory requirements Experience at a medium ... provides support for technical, quality, and project issues related to automated systems at our biologics based manufacturing facility. This person works under… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of BLA/MAA submissions, working knowledge and experience in document management systems , relevant therapeutic areas, regulatory requirements , and other aspects ... health authority requests; Proactively advise study teams regarding regulatory requirements and ICH guidance for clinical documentsParticipate in initiatives within… more
- Merck & Co. (Durham, NC)
- …perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, chillers, Cooling ... towers air compressors, waste deactivation systems )Clean Utility Equipment (eg HVAC, Clean steam generators, Water-For-Injection generation/distribution, reverse… more
- Aequor (Libertyville, IL)
- …our IT systems deliver the intended performance and meet regulatory requirements .Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and ... domains, and supporting technology, including manufacturing and supply chain ERP systems (eg Oracle, SAP).Working knowledge of regulatory requirements and… more
- Merck & Co. (Rahway, NJ)
- …Finance, IT, and other stakeholders regarding Compensation and Benefits functions/ systems /applications. Develop and execute a comprehensive product vision and ... new features and functionalities to enhance Compensation and Benefits systems .Drive Agile methodology across multiple projects, ensuring successful implementation on… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …is performed safely and meets contractual specifications, scheduling and financial requirements . Communicate status of projects to applicable project team Project ... and that all applicable commissioning, validation, GLP and GMP requirements are met or exceeded in accordance with project...non-business hours, to provide support for critical BMS, EMS systems Performs all job duties and responsibilities in a… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …priorities, forecasting, and identifying resources needed to make improvement to existing systems as needed. This role is the site Subject Matter Expert (SME) ... for site GMP Clean Utilities infrastructure and systems (WFI, Clean Steam, Pharmaceutical/Oil-Free Compressed Air, Process Gases, HVAC, etc.) and applications in… more
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