- Eisai, Inc (NJ)
- …will not be limited to the following activities:Provide oversight to eTMF system administration activities (ie study set-up, country/site updates, user access, ... IT to implement and maintain Eisai's global (Veeva) eTMF system . To provide oversight and guidance to ensure the...of relevant experience.Experience with Veeva Vault eTMF processes and systems is a must, including proficiency in writing test… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of BMS hardware and software Work with PM to support the commission the system , ensuring all devices and systems are correctly connected and functional Work ... maintaining and advising new projects on the Building Management System while collaborating with the Engineering team to provide...Design and Specification Contribute to design and specify BMS systems to control HVAC and other Critical Systems… more
- Tris Pharma (Monmouth Junction, NJ)
- …immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees and ... Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The incumbent uses … more
- AUROBINDO (Durham, NC)
- …with various Aurolifesystems such as LIMS, Quality Assurance Management System (QAMS),Waters Empower, Document Management System , Training ManagementSystem ... standards.Support internal and external regulatory inspection activities related tovalidated systems .Provide support to Quality Programs such as Data Integrity… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …position will be responsible for metrology support for instrument and mechanical system scheduling, planning, and work order management for cGMP Commercial Cell ... and utilities.Handles a variety of facilities & engineering department administrative support activities.Supports scheduling for metrology and facility and project… more
- Aequor (Thousand Oaks, CA)
- …4) Development of detailed specification, engineering documents, SOP and computerized system administration job plans. Testing of automation-based process ... equipment. 5) Ownership and administration of process control automation in a GMP regulated...New Technology Deployment. 9) Preferred Experience using the following systems : a. Lyophilizer System , Filling systems… more
- Eisai, Inc (Nutley, NJ)
- …area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. ... including audit and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice (GCP) oversight, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Working with eCompliance as Global Business owner for Veeva Vault/QDocs global system following governance modelEnsure administrative support is provided to QA ... of role based curriculum approach and resources for training administration .Lead establishment and enhancement of common Global infrastructure for training,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Aequor (Parsippany, NJ)
- …processing function; manipulation of large datasets, negotiation/conflict resolution. System Implementation and report writing.- Revitas/Flex Medicaid and advance ... in resolving dispute resolution, weekly pay run activities, SOX audits, system upgrade/implementation and ad hoc analysis. Essential Duties & Responsibilities… more
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