- Legend Biotech USA, Inc. (Raritan, NJ)
- …position reporting to the QA Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for ... the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team...providing quality oversight and guidance during the investigation of events that occur in the production of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Auditor will conduct internal audits, support regulatory inspections, and lead investigations to ensure process integrity and GMP compliance. Additionally, the role ... highly regulated environment.Key Responsibilities Lead manufacturing and cross functional investigations from end to end.Ensure thorough root cause analysis, impact… more
- Merck & Co. (Durham, NC)
- …Facility (MMSF). This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements ... hands on troubleshooting.- This individual will provide input to the deviation investigation process for determination of root cause, recommend corrective actions to… more
- Tris Pharma (Monmouth Junction, NJ)
- …projects regularly reporting status/issues to management, conducts laboratory investigations and recommends appropriate Corrective Action Preventive Action ... studies to support MV, method transfer and complex technical investigations and assists and trains lower level scientists.Responsibilities:Carries out… more
- Repligen (Waltham, MA)
- …ISO 9001 standard.Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation when required. ... Design History Files for the site. Assists with OOS investigations , OOT investigations and NCMR investigations .Completes required actions for identified… more
- Merck & Co. (Rahway, NJ)
- …community. The COE teams provide support to life cycle changes, investigations , trouble shooting and continuous improvement initiatives to guarantee the robustness ... to the portfolio.- This includes above site support for significant investigations , developing new solutions, establishing guidance and standard work. and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …that are able to manage changes from ideation at the non-conformation investigation change thought design and implementation. This involved cross collaboration of ... team with multiple organization particularly investigations , manufacturing, technical support and QA.Ensure MES team can prioritize and manage multiple tasks… more
- Twist BioScience (South San Francisco, CA)
- …the implementation of preventative actions identified through inspections or incident investigations .Assisting in the investigation of EH&S incidents, gathering ... information, and helping to develop initial corrective actions.What You'll Bring to the Team: Hands-on experience supporting or implementing EH&S programs, ideally within an industrial setting.Strong organizational skills with the ability to manage multiple… more
- Merck & Co. (Rahway, NJ)
- …transfer to internal and external manufacturing sites, manufacturing investigations , process validation, second generation process development and authoring ... For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process… more
- Merck & Co. (Durham, NC)
- …global technical support for strategic initiatives, projects, and/or investigations including:- authoring of technical documentation, process justifications, data ... product historical knowledge and best practices.Assist with complex process investigations , coordinating and supporting project activities under the guidance of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …business objectives.Support HR supervisory activities for designated team members.Support Investigations team by providing quality and compliance input for ... with (cross)functional departments to resolve issues related to batch review/release, investigations , and receipt of QC test results to allow for timely… more
- Merck & Co. (Durham, NC)
- …global technical support for strategic initiatives, projects, and/or investigations including:- authoring and approving technical documentation, process ... of product historical knowledge and best practices.Lead complex process investigations , including multi-site coordination and technical project management.Support technical… more
- Merck & Co. (Rahway, NJ)
- …anticipate, and solve significant scientific and technical challenges.Lead complex investigations into technical challenges related to design, manufacturing, and ... to grow their technical rigor to lead and/or contribute to investigations and resolutions.Cross-Functional Collaboration:Act as the primary technical advisor for all… more
- Eisai, Inc (Exton, PA)
- …systems. The position will participate in site deviation investigations , change control and corrective action/preventative action process.Essential Functions ... Provide high level technical assistance to site operating groups through investigations , controls systems assessments and design support. Proactively look for and… more
- Merck & Co. (Rahway, NJ)
- …technical support.- This includes above site support for significant investigations , complaints monitoring and rapid response activities. Develop and maintain ... - Able to guide key activities including development of standard work, investigations , and problem solving Strong strategic and analytical thinking, with a focus… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issue and handles project. This position prepares trainings, supports CAPA investigations , case review, documentation reviews in collaboration with the ICSR ... basis. Management of escalated case processing issues/troubleshooting. Supports CAPA investigations / implementation.ICSR Standards Oversight: Acts as subject matter… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs. They will further serve as the scientific expert supporting digital pathology investigations and as a point of contact for developing and managing external ... partnerships in support of translational science and CDx programs. They will provide the expertise to create and integrate pathology datasets with broader multi-omic analyses to support hypothesis-driven translational research efforts with direct impact across… more
- Merck & Co. (Durham, NC)
- …in at least 1 manufacturing area.Technical writing experience, ie investigations , change requests, standard operating procedures, batch records, protocols.-Must be ... able to work both independently and within multi-functional teams in a fast-paced environment.-Experience with pharmaceutical process systems including PAS-X, DeltaV, SAP, RtReports, GLIMSAt least four (4) years GMP manufacturing/processing experience or at… more
- Merck & Co. (Durham, NC)
- …for SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces ... an inclusive team culture including significant interaction with operations, quality, automation, technology, and other groups as required.Key Duties:Ability to perform routine maintenance tasks, work with and troubleshoot complex process systems, including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to reduce non-conformances in supported areas by proactively driving compliance.Support Investigations team by providing quality and compliance input for continuous ... improvement and remediations.Serve as a backup for approving 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, cross-functional environment to complete… more
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