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Coordinate/author/review drug substance relevant sections of regulatory documents (IND, IMPD, NDA and MAA) Qualified candidates must have a PhD in synthetic/organic chemistry or related scientific field with 15+ years’ experience in drug substance development and manufacturing and a proven track record in developing and scaling up chemical process to kilo lab, pilot plant and commercial plant scales.
ExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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In this role, the Research Scientist will author and/or review assay development plans, project reports, procedures, and other assay-related documentation and independently execute experiments according to project plans.
ExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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At least 1 first-author publication (published or manuscripts submitted for publication) in high-quality specialty or general readership journalsExperience in in vivo disease models, tissue harvesting, dissociation, and cell isolation.
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Guides and ensures that the clinical study documentation (documents, images and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Performs other administrative documentation and record keeping, such as accountability and statistical reports, billing forms, student intern evaluations, performance evaluations, etc. Ensures clinical documentation is complete and according to departmental standards.
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Provide statistical expertise to support protocol development, study set up and conducting; author or peer review Statistical Analysis Plan (SAP); review data specifications and TFL shell; provide statistical QC as needed; co-author or peer review clinical study report and publications.
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Performing annual account reviews, periodic reviews Performing GMP data quality assessments and managing deviations Managing document review and approval workflows in a global document management system Working with data archiving and electronic document management systems (in house systems are OpenLab and Veeva Quality Docs) Manage IQOQ and UAT – write and execute test scripts, author test summary reports.
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Primary Sterile Processing responsibilities include receiving instrumentation, sorting and decontamination of procedural items and instrumentation; inspection and assembly of minor instrument groups and instrument trays; identification of respective sterilization method and cycle selection, accurate documentation for all sterile processes; and accurate inventory assignment relating to the case building process.
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Includes but not limited to water mains, services, hydrants, valves, meters, and sewer mainsResponsible for quality of work performed by the crew in the absence of a working foreman or SupervisorMaintain logs and documentation of all maintenance done on the city’s water distribution and wastewater collections system.
$30.72 - $34.57 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This involves the development of a control system architecture, selecting the components to be used, detailing schematic diagrams and system documentation, programming controllers (PLC, DCS, RTU), programming the process visualization (HMI/SCADA), developing databases for archiving/displaying historical system data and implementing/commissioning the control system at the client’s facility.
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Participate in the development of electronic clinical data case report forms, author medical data review plan, review data integrity and trend, and contribute to study monitoring and data analysis.
ExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Understands, conducts, and documents appropriately Dialysis/Apheresis machine safety tests/alarm tests, equipment calibration, dialysate testing, machine safety tests, functional testing, and internal and external disinfection on all water & dialysis machines, and complies with the documentation/notification standards per FMS policies.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Maintain daily and monthly progress notes, shift checklists, and other program documentation according to DDS, DMH, and all applicable regulatory standards. Provide services to individuals according to, DDS, DMH, MassHealth, HUD, DPH, CARF, all applicable regulatory standards, and Bridgewell policies and procedures.
$15 - $18.85 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Records and Accessioning Archivist plays a key role in TARC's archival accessioning, processing, and collection stewardship activities and has primary responsibility for accessioning both physical and digital collection material and facilitating the management of collection documentation files for TARC. The Records and Accessioning Archivist serves as a primary point of contact for departments and offices at the university seeking to transfer records to the University Archives.
Starting at $57,900 - $72,450Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Hands on operation of the pilot plant including documentation of operating conditions. Sublime's breakthrough process replaces the industry's legacy fossil fuel-fired kilns with an electrochemical system that operates at ambient temperature and eliminates the use of fossil fuel and limestone, resulting in a zero-carbon, low-embodied energy cement.
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author documentation jobs in Burlington, MA
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