- Aequor (Thousand Oaks, CA)
- …experience managing in Track Wise or Veeva Systems Basic project management skills required.The Specialist Manufacturing is expected to own and execute ... and Investigations (SICAR /EN), and Change Control quality records. This Specialist Manufacturing will act as the External Supply representative across functional… more
- Merck & Co. (Rahway, NJ)
- …skills: Three (3) years of experience in managing regulatory submissions and document management systems such as Veeva Vault and RIMSStrong knowledge of ... to regulatory operations.Experience in managing regulatory submissions and document management systems .Familiarity with electronic submission formats and tools… more
- Novo Nordisk Inc. (Seattle, WA)
- …Nordisk within a specified geographic area, engaging with selected health systems , key academic centers, specialists, primary care providers, and other stakeholders. ... a frontrunner in the cardiometabolic care market. The Senior Ecosystem Portfolio Specialist is responsible for achieving sales targets by effectively promoting Novo… more
- Merck & Co. (North Wales, PA)
- Job DescriptionJob Summary:The Clinical Specialist position is a combined position of clinical scientist and study management duties supporting one or more ... of a clinical scientist, study manager, or program lead, the Clinical Specialist may be responsible for but not limited to:-Job Responsibilities:Maintain clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Batch Disposition Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThis exempt-level position is responsible ... established internal contacts.Consistently perform tasks in adherence with safety policies, quality systems , and cGMP requirements, as well as according to state and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Specialist , Global Pharmacovigilance will be responsible for some or all of the following core activities:Case review/approval for assigned ... stakeholders (eg, Competent Authorities) for products for which the Senior Specialist is responsiblePV Statement preparation in compliance with relevant regulations,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking an Operations Support Specialist as part of the Technical Operations team based in Raritan, NJ.Role OverviewThe Operations Support ... Specialist will be part of the Technical Operations team...floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and… more
- Novo Nordisk Inc. (Durham, NC)
- …area of this role will be Audits and Inspections. The Sr. QA Area Specialist will host internal audits, serves as facilitator during and coordinate all activities ... Quality processes. Relationships Manager, Quality Assurance. Essential Functions Ensures plant systems batch release & relevant quality processes are compliant with… more
- Aequor (Seattle, WA)
- …master data in APEX, GPS, Oracle, SAP, and/or other comparable planning/scheduling systems is preferred. Responsibilities:The Master Data Specialist will be ... setting is preferred. Cell Therapy experience is a plus.Data Analysis/ Management experience is required.Highly Preferred:Experience working in or managing master… more
- Merck & Co. (Rahway, NJ)
- …Office of General Counsel is seeking an experienced Trademark Renewal Specialist to provide trademark maintenance and docketing support to the Intellectual ... documentation to resolveElectronically file relevant renewal-related documentation into document management system in accordance with established proceduresReview amended trademark… more
- Merck & Co. (Baton Rouge, LA)
- Job DescriptionThe Automation Senior Specialist will support startup, commissioning, and qualification on capital projects in support of our company's Animal Health ... training, day to day operations support. T he Automation Senior Specialist will work closely with engineers, equipment suppliers, automation engineers, commissioning… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking QA Lab Oversight Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Lab Oversight Specialist ... tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Critically support investigations and reports, interpret results, and… more
- Merck & Co. (Rahway, NJ)
- …to ensure high quality data and timely and complete synchronization between systems . Acts to resolve all issues and discrepancies as data stewards responsible ... creation, modification and change control for SAP BPC. The LPT COE Sr. Specialist is responsible for supporting BPC PLANIT US Operations and tickets management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …PIC/S, MHRA)Operational experience with electronic quality systemsExperience with Document Management Systems (TruVault/Veeva) is preferredStrong written and ... Legend Biotech is seeking QA, Document Control Specialist (1st Shift) as part of the Quality...exempt level position with responsibilities for supporting the document management process within a cell therapy manufacturing facility to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strong communication skillscGMP manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards ... Legend Biotech is seeking a Maintenance Specialist I (3rd shift) as part of the...pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking CQV Specialist I as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible for ... be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues, deviations, corrections and remediation… more
- Merck & Co. (Rahway, NJ)
- …within the clinical supply planning function. - Proficiency in using supply chain management systems and software, including experience with ERP systems ... management . - Technical Proficiency: familiarity with supply chain systems and software ( eg SAP or Oracle) and...SAP), demand planning tools, and inventory management systems . - Proven record in project / portfolio … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to maximize your potential with us? The Position Security Operations Specialist II will identify and respond to IT Security incidents. The individual will ... internally with Global Information Security and Global Security Operations management , Global IT Operations Infrastructure Service Managers and Architects, IT… more
- Novo Nordisk Inc. (Durham, NC)
- …on Days. Relationships Manager, Quality Assurance. Essential Functions Ensure plant systems batch release & relevant quality processes are compliant with regulations ... & approval of validation activities associated with projects, new systems , changes to existing systems & maintaining...support all processes & functions in Department Quality Risk Management Make decisions on quality & compliance issues with… more
- Merck & Co. (Rahway, NJ)
- …controls, ISO 13485, deviation management , change control, risk management /ISO 14971-2019 and the fundamentals of documentation structure/ systems - Experience ... combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled syringes,… more
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