- 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
- 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
- Cipla (Hauppauge, NY)
- …ensure compliance with 21 CFR Part 11 requirements, particularly ensuring that electronic signatures, timestamps, and system access are appropriately documented ... records and associated audit trails comply with 21 CFR Part 11 requirements for electronic records and signatures, ensuring that all system actions are secure,… 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
- Merck & Co. (Rahway, NJ)
- …data structures; capacity to seamlessly assimilate to new projectsUnix operating system experience; SQL experience; systems and database experienceThrives ... Skills: Computer Science, Data Analysis, Data Management, Data Modeling, Electronic Medical Record (EMR) Systems , Electronic … more
- Merck & Co. (Rahway, NJ)
- …The Associate Director of Regulatory Submissions Archive Operations serves as the Business System Owner (BSO) for the Veeva RIM Submissions Archive and is also ... as the BSO for the Veeva Vault RIM Submissions Archive, overseeing system development, maintenance, enhancements, and monitoring. Liaise with IT, Learning &… 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
- 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
- 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
- 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
- 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
- Syner-G BioPharma Group (Boston, MA)
- …strategic guidance and hands-on expertise to streamline operations, enhance quality systems , and ensure regulatory compliance, empowering our clients to navigate ... requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.Lead… 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
- Eisai, Inc (Nutley, NJ)
- …reports and Non-Operating P&L activity to Senior Leadership; execute electronic funds payments and inter-co transactions; execute foreign exchange transactions; ... financial and strategic initiatives; responsible for overseeing Treasury Workstation system (Kyriba); prepare annual budget, periodic forecasts, and conduct variance… more
- Merck & Co. (North Wales, PA)
- …trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertiseDesigns and develops complex programming algorithmsAbility ... vaccine regulatory application submission experience including the development of electronic submission deliverablesExperience assuring programming consistency across protocols and… more
- Aequor (Thousand Oaks, CA)
- …for scale-up culture and banking activities with primary focus on closed- system multi-layer vessels (HYPERStack®) for adherent cell lines. Lead process development ... applicable SOPs. Operate lab and automation equipment, including centrifuges, HPLC systems , incubators, freezers, LN2 dewars, vial fillers, labelers, and cappers.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …willing to learn and be proficient in eLIMs, S4HANA (SAP) , MES (Manufacturing Electronic Batch Record), and a Learning Management System . Electronic Batch ... Record), and a Learning Management System .Strong interpersonal skills and the ability to work well in a team environment is a must.Language: English#Li-Onsite#Li-DD1The anticipated base pay range is$66,063—$86,706 USDBenefitsWe are committed to creating a… more
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