- Repligen (Hopkinton, IA)
- …Management System . This role is responsible for assisting the document control department in processing documentation requests. They will work closely with ... OverviewWe are seeking a Document Control/QA Associate I to join our growing...to meet established deadlines (paper and electronic).Maintains related database systems , if applicable, logs and complete forms/records as required.Adheres… more
- Aequor (Athens, GA)
- …sites / activities. Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy ... systems . Electronic Document Management (controlled documents, regulatory submission documents): Create and...systems . Must be able to follow precise computer system instructions with high attention to detail and minimal… more
- Merck & Co. (Rahway, NJ)
- …to ensure practices are accurately reflected. Assist in SOP and quality-related system document approval. Support metrics by summarizing findings during ... performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Repligen (San Diego, CA)
- …by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and ... and on site at customer locations. The type of support will include system qualifications for Installation and Operation (IQOQ), product testing, system … more
- Repligen (Clifton Park, NY)
- …single-use state-of-the-art single use components and innovative storage and transfer systems that optimize fluid transfer and reduces the number of connections ... This role requires in-depth knowledge and experience of manufacturing solutions and systems as well as solves complex problems and takes on new perspectives… more
- Eisai, Inc (Nutley, NJ)
- …by Clinical OperationsMaintains sponsor team member staff assignment list for Eisai systems eg. eTMF, EDC, IRTAssist with tracking SAE safety reports, collating ... clinical team for designated projects, communications, and associated documentation Document Creation and Management: Assist with creating, updating and maintaining… more
- Merck & Co. (Rahway, NJ)
- …from internal teams and provide training on vendor management and e-billing systems . Assist in firm rate negotiations, matter budgeting, and billing issues. Foster ... technology solutions to improve efficiency and reduce legal costs. Help document legal processes/procedures to keep our internal knowledge management portal updated.… more
- Merck & Co. (North Wales, PA)
- …to meet the value evidence needs of payers, advisory committees health systems , and clinicians.The incumbent can generate these plans based on direct interactions ... purposes.Develops and evaluates health programs leveraging different parts of health care systems that can enhance value and use of products.Implements programs to … more
- Merck & Co. (Durham, NC)
- …Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved vendors for calibrations not performed by site ... to ensure appropriate instrument turnover to site.Expand knowledge into other systems , capable of managing change in the pursuit of continuous improvement.Support… more
- Merck & Co. (Rahway, NJ)
- …standards for how automation interacts with ITSM, detection engines, identity systems , and risk scoring frameworks.Serve as lead integrator between the Automation ... AI Lead to ensure insights are engineered into secure, responsive systems .Required QualificationsBachelor's degree in Computer Science, Engineering, or a related… more
- Merck & Co. (Austin, TX)
- …role-you will help design and deliver the next generation of cybersecurity systems through secure, intelligent automation. You will build workflows that integrate ... function focused on transforming how cybersecurity operates-less detection, more design. The systems you build will be foundational to how we scale AI, automate… more
- Merck & Co. (Boston, MA)
- …current with emerging pharmaceutical information tools and databasesSupporting document delivery requests and end-user requestsObtaining journal articles and ... requests with Library team membersManaging access to external information systems such as databases, literature platforms, and pharmacopoeiasCollecting and reporting… more
- Merck & Co. (Durham, NC)
- …Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved vendors for calibrations not performed by site ... to ensure appropriate instrument turnover to site.Expand knowledge into other systems , capable of managing change in the pursuit of continuous improvement.Lead… more
- Twist BioScience (South San Francisco, CA)
- …and in alignment with business needs and strategic objectives.Gather and document detailed business requirements for projects, ensuring clarity and alignment across ... to technical product management, customer relationship management, or products, systems , or applications experience.Excellent communication, collaboration, and relationship-building skills.Ability… more
- Twist BioScience (South San Francisco, CA)
- …Safety Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems (eQMS) Experience ... and collaborate with the Business Process Owner and EQMS users to develop and document configuration changes to meet business need Perform other duties & projects as… more
- Merck & Co. (Rahway, NJ)
- …solutions to business needs by designing and implementing new data management systems Employ innovation and technology solutions to manage data warehousing more ... and Strategic Roadmap, supporting the organization's transition toward future-ready systems and modern data architectures. Primary Activities Design and develop… more
- Repligen (Waltham, MA)
- …supplier changes. Nonconforming Material Request (NCMR) Process and AnalysisInitiate and Document NCMRs: Identify and document nonconforming material detected ... Proficiency in conducting risk assessments and quality audits. Experience with eQMS systems or digital audit tools Familiarity with regulatory standards (FDA, GMP,… more
- Merck & Co. (Upper Gwynedd, PA)
- …communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory leadership as needed in product ... responses to health authority questions per established business processes and systems .-Identify, communicate and escalate potential regulatory issues to GRACS CMC… more
- Eisai, Inc (Exton, PA)
- …and technologies, working with R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at the company's discretion.5. ... be responsible to maintain and/or enhance the production area systems and technology to remain compliant with regulations and...Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in… more
