- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Validation Specialist role is an exempt level position with...position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems,… more
- Aequor (Framingham, MA)
- …encompasses temporary, support to be the lead point of contact for the shipping validation program during a leave period for the primary program owner. This will ... design of transport qualification strategies, reviewing and approving transport validation deliverables and accountability for on-time delivery of transport… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and ... with company policies, SOPs, and state, federal and local laws Performs validation of analytical methods and release/stability testing for raw materials, IP, FP… more
- Aequor (Vacaville, CA)
- …of cGMP or equivalent regulations. Minimum of two years' experience in Validation or equipment qualification is desired. Ability to make sound decisions about ... scheduling and managing of priorities. Flexibility in problem solving, providing direction and work hours to meet business objectives. Knowledge/Skills/Competencies: Possesses strong verbal and written communication skills and the ability to influence at all… more
- Merck & Co. (Rahway, NJ)
- …products. This position will involve oversight of late-stage method development, validation , and life-cycle management of methods but mainly global method transfer ... Research Laboratories division, continuous improvement of analytical methodology, assay validation , analytical technical transfer, and Biologics License Application preparation.… more
- Merck & Co. (Rahway, NJ)
- …post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- Eisai, Inc (Exton, PA)
- …position will also work with internal and external personnel to develop validation documentation and implement validation plans, and direct validation ... alarms as well as to alleviate nuisance alarms. Support Validation in their qualification work as well as in... in their qualification work as well as in validation maintenance activities. Maintain all automated system design documentation… more
- BioAgilytix (Durham, NC)
- …best suited for someone with deep expertise in method development, GxP-compliant validation , and both targeted and untargeted analysis using chromatography and mass ... project deliverables with client timelines and expectations.Lead assay development, validation , and sample analysis of biologics, proteins, peptides, ADCs, and/or… more
- BioAgilytix (San Diego, CA)
- …and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation , and sample analysis under GxP, while also playing a key role in ... with clients to assure successful on time execution of assays, validation , and sample analysis under GxPs.Prioritizing tasks and managing schedules efficiently.Meet… more
- Merck & Co. (Rahway, NJ)
- …play a crucial role in the supporting the development, analytical validation , and testing of histopathology-based assays for clinical implementation and advancing ... by our company's therapeutics.Collaborate in the development and analytic validation of digital pathology algorithms.Interface with scientists and physicians in… more
- Merck & Co. (North Wales, PA)
- …& electrical knowledge, automation expertise, AutoCAD/SolidWorks competency, equipment validation & qualification, Lean Manufacturing/Six Sigma, GMP, Safety ... and quality systems, particularly in process and equipment qualification & validation , root cause analysis, change control, deviation management, and cleaning… more
- Merck & Co. (Rahway, NJ)
- …transfers across the network inclusive of aligning the control and validation strategies. Minimum Education Requirements and Experience: Bachelor of Science (BS) ... supply, including components, process, and equipment, as well as qualification and validation , medical device design controls and device risk management, and design… more
- Merck & Co. (Rahway, NJ)
- …transfers across the network inclusive of aligning the control and validation strategies. Minimum Education Requirements and Experience: Bachelor of Science (BS) ... supply, including components, process, and equipment, as well as qualification and validation , medical device design controls and device risk management, and design… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pathology strategies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to proposed ... pathology, spatial analyses, NGS, immunoassay, proteomics including expertise in assay validation required Travel: Ability to travel up to 10%. Global travelDaiichi… more
- Merck & Co. (Durham, NC)
- …Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control ... tools and calibration equipment)-Assist with execution of calibration, automation, validation and additional testing, as requiredDecisions are guided by policies,… more
- Insmed Incorporated (San Diego, CA)
- …System Design & Development:Lead the setup, development, and validation of EDC systems, including configuration settings, integration with ... FDA, EMA, ICH-GCP) and company SOPsPerform user acceptance testing (UAT) and validation of EDC systems to ensure data integrity and accuracyImplement and monitor… more
- Merck & Co. (Rahway, NJ)
- …including (but not limited to) signal detection, prioritization, validation , assessment, and recommendation for actionSignal management statement preparation ... trainingProvide business support for pharmacovigilance database systems (eg, review validation documents and execute User Acceptance Tests (UATs) for functionality… more
- Merck & Co. (Durham, NC)
- …Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation . Position Description: Durham-Technology consists of the Automation/MES, ... Deviation Management, Manufacturing Technical Operations, Validation , and New Product Technical Transfer Departments.The Associate Specialist - Process Engineer will… more
- Merck & Co. (Rahway, NJ)
- …familiar with using statistical software for design of experiments.Experience with qualification, validation , and transfer of assays to a GLP or regulated laboratory ... Chromatography (LC), Management Process, Matrix Management, Mentoring Staff, Method Validation {+ 5 more}-Preferred Skills:Job Posting End Date:10/4/2025 *A job… more
- Merck & Co. (Rahway, NJ)
- …practices across multiple source systems . Support the extraction, transformation, and validation of process and analytical data to ensure consistency and quality ... and document formats like PDF, enabling effective data extraction, validation , and integration.Experience in data standardization, modeling, and semantic ontologies… more
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