- Aequor (San Diego, CA)
- Position Summary: Responsible for planning, writing, implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems . Serve as ... on and interpretation of global GxP guidance and regulations of computerized systems , electronic records, electronic signatures, and data integrity requirements.… more
- Merck & Co. (Rahway, NJ)
- …candidate will support the deployment and sustainment of a Manufacturing Execution System (MES) at the FLEx Center to enable Electronic Batch Records (EBR), ... The Specialist will help to ensure that the MES system functionality will maximize business benefits and meet operating...role in Rahway, New Jersey and reports to the Systems Process Lead Director at the FLEx Center in… more
- Aequor (San Diego, CA)
- Position Summary:Responsible for planning, writing, implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems .Serve as ... and interpretation of global GxP guidance and regulations of computerized systems , electronic records, electronic signatures, and data integrity… more
- Insmed Incorporated (NJ)
- …Annex 11, ICH Harmonized Guideline Good Clinical Practice (GCP) E6(R3), Computerized Systems Used in Clinical Trials, Computer System Validation, Quality ... or San Diego location. The Sr. Quality Engineer, Digital Systems Quality Assurance (QA), is responsible for providing quality...laboratories and other GxP areas, with a focus on data integrity, validation, and inspection readiness. The Sr. Quality… more
- Merck & Co. (Rahway, NJ)
- …requirements and harmonized strategy.Drive alignment among global stakeholders on master data definitions, templates, and system usage to enable consistent ... cross-functional execution and data / system integration.Innovation: Promote automation and AI readiness by ensuring the integrity of master data across the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effortsIdentify, develop, and implement system improvements for local MES system .Align global process strategy and data governance initiativesEnsures Audit ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based in Raritan, NJ. Role… more
- Merck & Co. (Rahway, NJ)
- …technologies, small molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to ... to room temperature shipments, distribution (shock and vibration) qualification, and data collection systems for distribution (eg temperature monitors).- To… more
- Insmed Incorporated (NJ)
- …possible for patients with serious diseases. Reporting to the Associate Director, Quality Systems , you'll leverage your data science and AI skills to identify ... the Role:We're looking for a Summer Intern - Digital Systems QA on the Quality Assurance Team to help...data to build predictive models. Improve various digital systems by identifying opportunities where AI tools can be… more
- BioAgilytix (Durham, NC)
- …Data Integration & Infrastructure Development:Develop ETL processes to automate data extraction, transformation, and loading from core systems (LabVantage ... solutions for centralized data storage.Create APIs to enable real-time data sharing between systems , with a focus on operational efficiency and data … more
- Aequor (Morris Plains, NJ)
- …dataTechnical competencies will require the use of MES, LIMS, ERP (SAP) computer systems along with Microsoft Excel and WordCompile data in memo/report format ... Job Title: Manufacturing & Sciences Technology Data CoordinatorPay range: - based on qualificationsCollect and...driveWork with QA to ensure accuracy and integrity of data being transmitted to clientData upload to client will… more
