- Formation Bio (New York, NY)
- …to join the Data Platform team at Formation Bio to help transform Electronic Health Records (EHR) data into structured, analytics-ready assets. In this role, you'll ... logic, assumptions, and data lineage in collaboration with metadata and cataloging systems . Contribute to the evolution of the Data Platform by helping define… more
- Insmed Incorporated (NJ)
- …the nature of the documents being managed.Proficiency with Veeva or similar electronic document management systems .Strong attention to detail and organizational ... science, we're in. Are you?About the Role:We're looking for a Quality Management System (QMS) Specialist on the Analytical Development team to help us expand what's… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …long-term objectives.Ability to identify/remediate gaps in processes.Operational experience with electronic quality systems is required.Proficient with using ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- …of standard departmental SAS macros, R packages and tools-Unix operating system experience; SQL experience; systems and database experienceExperience assuring ... eligibleforERPSPjobsBARDS2020VETJOBSEBRGRequired Skills: Accountability, Clinical Development, Computer Science, Database Management Systems (DBMS), Data Management, Data Modeling, Electronic … more
- Insmed Incorporated (NJ)
- …role serves as the IT System Owner for the Learning Management System and compliance IT systems , which includes supporting GxP-regulated applications, while ... while ensuring system integrity and regulatory adherence throughout the system lifecycleEnsure systems meet business needs and operational requirements while… more
- Cipla (Fall River, MA)
- …Function as SME for IT related activities of QMS platforms and other electronic systems including digital platforms which need compliance to 21CFR, Part ... Pharmacology, Biochemistry, etc). Basic knowledge and Industry experience of Quality System relevant to electronic records storage, retrieval, archival and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Document Management system users with workflow handling and electronic system usage.Manage the periodic review process for procedures.Issuance ... ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).Operational experience with electronic quality systems .Experience with Document Management Systems … more
- Eisai, Inc (Baltimore, MD)
- …technical oversight and troubleshooting for eCTD submissions and related systems .Operational ExcellenceEnsure consistent application of GSM global procedures and ... submissions management, process development, standards development and compilation of electronic major submissions requiredProficient with US and EU submission… more
- Aequor (Hicksville, OH)
- …other data in non-network process equipment. Backup of electronic records, system files, and operating systems . Assist with review, investigation and ... and qualification of new equipment and controls; supports facilities systems and services as required. Develops low to mid-level...inspection of local machine data, system configuration management, version control and retention of PLC… more
- Merck & Co. (Rahway, NJ)
- …strong attention to detail in completing GMP documentation, proficiency in electronic systems , and participation in continuous improvement projects.- Positions ... of inspection results and maintain accurate records of findings in an electronic system .- Knowledge of PAS-X is preferable.GMP: Follow established inspection… more
- Merck & Co. (Rahway, NJ)
- …strong attention to detail in completing GMP documentation, proficiency in electronic systems , and participation in continuous improvement projects.- Positions ... of inspection results and maintain accurate records of findings in an electronic system .- Knowledge of PAS-X is preferable.GMP: Follow established inspection… more
- Cipla (Fall River, MA)
- …Preparation of qualification and validation documents of equipment and computer system . Preparation and qualification of e-batch record & e-Log Book. Knowledge ... SDS, FS, validation plan, FAT, SAT, IQ, OQ,PQ, validation certificate, PIR,RTM, electronic signature, electronic reports. Knowledge of 21 CFR and implementation.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be responsible for management and delivery of the project plans for electronic batch record (EBR) updates and system improvements, support applicable ... of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management support… more
- Cipla (Hauppauge, NY)
- …and electronic analyzing and testing equipment. Thorough knowledge of electronic components, digital and analog circuitry, hydraulic systems , and machine ... Diagnose and solve electrical problems for manufacturing and packaging equipment and systems . Install, service, calibrate, and update electrical systems . Repair… more
- Eisai, Inc (Nutley, NJ)
- …Listings for all of Eisai's products.Maintain centralized labeling repository within Eisai's electronic document management system for all global labels at ... and approval. Manage labeling development, review and approval workflows within the electronic documents management system and track the timely and consistent… more
- Merck & Co. (Rahway, NJ)
- …strong attention to detail in completing GMP documentation, proficiency in electronic systems , and participation in continuous improvement projects.- Positions ... to maintain good manufacturing practice (GMP) operations, using paper-based and electronic systems .Maintains detailed knowledge of process equipment and… more
- ALPCO (CA)
- …with OEM field service organizations and IT departments for integrated system /network setup. Maintain field service inventory, records, and documentation. Contribute ... to technical manuals, troubleshooting guides, and electronic reference resources. Apply strong analytical skills to resolve complex technical issues… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …11/Annex 11, PIC/S, MHRA).Operational experience with electronic quality systems .Familiarity with core Quality Management System processes.Strong written and ... tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Review change controls, SOPs, and other documentation.Require minimal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …printed labels and documents prior to use on the manufacturing floor.Utilize multiple electronic quality systems , batch records and SAP.Work in a team based, ... the assigned tasks.Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems .Utilizes tools… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process-related protocols and documentation.Provide technical quality oversight for electronic batch records.Support manufacturing and technical operations teams in ... resolving complex scientific / technical problems.Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry… more
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