- BioAgilytix (Durham, NC)
- …role independently with attention to detail and minimal oversightAbility to perform technical review of data following GxP regulations and scientific ... right at home here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical , scientific, and compliance review of data and documentation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QC Data Reviewer as part of the Quality team based in Raritan, NJ. Role Overview The ... QC Data Reviewer is an exempt level position responsible for reviewing...in a controlled GMP environment. Key Responsibilities Perform peer review /approval of laboratory data including but not limited to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role Overview ... The Lead QC Microbiology Data Reviewer is an exempt level position with responsibilities for...commercial operations in a controlled cGMP cleanroom environment. Create, review and approve relevant QC documents, logbooks, SOP's and… more
- BioAgilytix (Boston, MA)
- …data, and reports (documentation according to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and ... metrics data used to monitor the QC reviewsFollow QCT SOPsResponsible for second-level technical reviews of documents prior to review by the project manager… more
- Aequor (Thousand Oaks, CA)
- …such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical ... to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (eg, CD,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …coordination and execution of process and equipment improvement programs, creates technical reports, reviews completed quality records, generates quality comment and ... responses and has ability to provide training support. Prior experience as a Technical Writer, or peforming Technical Writing, is preferred for this position.… more
- Aequor (Swiftwater, MN)
- DescriptionThe OneLIMS EM project technical writer is responsible for supporting on-time implementation of OneLIMS EM global system for the Swiftwater, PA site. The ... associated training modules.KEY RESPONSIBILITIES: Design, develop, and update required technical documentation Assist with the editing of quality documents (SOP's,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer 's guides, etc- Global Biostatistics Data Management (BDM) Strategy to ... - Bachelor's Degree an accredited institution in a science or in a technical field preferred - Master's Degree preferred Experience Qualifications - 10 or More… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer 's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to ... Bachelor's Degree an accredited institution in a science or in a technical field preferred- Master's Degree preferred Experience Qualifications- 10 or More Years… more
- Merck & Co. (Durham, NC)
- …direct in-line Quality support for all compliance and environmental monitoring matters, review of atypical events including accessing product impact for EM events, ... providing Quality oversight to alarm events during processing, review and approval of incursions, review and approval of batch record documentation, and… more
- Catalent (PA)
- …review meetings and support the site selection process.Hold and/or participate in technical review meetings with prospective clients and current partners to ... review drafted proposals throughout the lifecycle of an opportunity.Lead internal technical review meetings to ensure alignment with site capabilities and… more
- Merck & Co. (Durham, NC)
- …to meet schedule, budget, benefit realization and other project objectives.Provide technical guidance/support including authoring or review and approval of ... Senior Specialist for Manufacturing Automation is responsible for providing automation technical support for the building. Responsibilities may include, but are not… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global R&D Learning Experience Leader to develop and manage impactful scientific and technical learning programs for our R&D associates. This role will create and ... continuously improve scientific and technical learning across multiple modalities and formats using an...program from content to delivery. ** Prior to applying, review the Education & Qualification section - Be sure… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations. Write and/or review manufacturing process ... technical /scientific recommendations and support and manage applicable change controls. Technical assessor of change controls. Provide review of process flow… more
- Catalent (St. Petersburg, FL)
- …enhancements to the QMS.The QA Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited ... with the highest integrity, in partnership with Catalent St. Petersburg's internal technical departments. This position is expected to serve as a representative for… more
- Merck & Co. (Rahway, NJ)
- …individual to work in a fast-paced job that provides a high degree of technical , project, and people management responsibility. - This SSO Facility Lead role within ... the SSO Pilot Plant leverages significant depth and breadth of scientific, technical , and operational experience to lead and support facility operations, process… more
- Aequor (Devers, TX)
- …cGMP requirements. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent ... effectively multi-task. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …non-functional business requirements Excellent technical writing, document organization, technical document review and analytical thinking skills are ... Position The Senior Solutions Architect (Commercial Data Mgt & Analytics) is a technical leader with a deep understanding of business goals, business processes and… more
- Merck & Co. (North Wales, PA)
- …work independently within a cross functional framework and will involve detailed technical writing and review .A high degree of creative thinking, ... employees. Activities will include developing, documenting, and maintenance of technical business solutions, reviewing and approving medical device/combination product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary The purpose of this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and ... to support outsourced programming activities and be responsible for the programming technical decision. By guiding other internal programmer or by self, perform… more
