- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance… more
- Eisai, Inc (Nutley, NJ)
- …and HCP payment records Serve as the operational lead for Eisai US's Compliance Monitoring Program, managing internal resources and external vendors Communicate ... Support investigations by conducting data reviews to identify potential compliance risks or violations Partner with Commercial Operations, IT, and Finance to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessment, and continuous improvement.The Compliance Auditor will conduct internal audits, support regulatory inspections, and lead investigations to ... determination.Work cross functionally with SME's and Quality to ensure robustness of investigations , as well as accuracy and ensuring compliance .Support and… more
- Merck & Co. (Lower Gwynedd, PA)
- …PDMB Regulated Bioanalytics Department is seeking a Director to lead the Compliance team within the Late Development (AdVAnce) Vaccines bioanalytical group located ... and efficacy clinical patient data required for regulatory filings. The compliance team will ensure all operations, documentation, procedures, and filings meet… more
- Merck & Co. (Lower Gwynedd, PA)
- …Laboratory Documentation, Laboratory Information Management System (LIMS), Laboratory Investigations , Process Improvement Projects, Project Management, Regulatory ... in Lower Gwynedd Township, PA.-As a member of the Late Development Vaccines Compliance team, the successful candidate will oversee the quality and compliance … more
- Merck & Co. (Rahway, NJ)
- …process characterization, control strategy development, technology transfer to internal and external manufacturing sites, manufacturing investigations , ... in Biologics Cell Culture Sciences group and working in conjunction with internal and external partners, this individual will support late stage and commercial… more
- Merck & Co. (Rahway, NJ)
- …products to patients globally.The incumbent is expected to interact closely with internal sites and external partners in our Company network in identifying ... to pharmaceutical drug substance and drug product development, GMP compliance in commercial manufacturing and data integrity.Responsibilities Include:Lead and/or… more
- Merck & Co. (Rahway, NJ)
- …and compliance of our company's product portfolio across the internal and external networksThe candidate is expected to build inclusive, collaborative ... and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise wide… 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)
- …Chromatography & Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the QMS including ... but not limited to Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change...host for site auditsMaintain risk-based strategy for overall Quality compliance across the organization and in support of the… more
- Merck & Co. (Rahway, NJ)
- …expertise in the design, development, and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA ... anticipate, and solve significant scientific and technical challenges.Lead complex investigations into technical challenges related to design, manufacturing, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …meet business objectives.Support HR supervisory activities for designated team members.Support Investigations team by providing quality and compliance input for ... compliance .Ensure readiness of records for regulatory inspections and internal audits.Review, compile, and organize batch data.Review, compile, batch documents… more
- Merck & Co. (Rahway, NJ)
- …the successful completion of projects. This includes technical support to the internal and external manufacturing sites as well as Third Party Logistics providers ... designs.- The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and 3rd party logistics… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/ internal audits.Collaborate with site ... reagents.Strive to reduce non-conformances in supported areas by proactively driving compliance .Support Investigations team by providing quality and … more
- Merck & Co. (Rahway, NJ)
- …and compliance of our company's product portfolio across the internal and external networksThe candidate is expected to build inclusive, collaborative ... partnerships with internal and external stakeholders, such as packaging and manufacturing...platform stewardship.- This includes above site support for significant investigations , complaints monitoring and rapid response activities. Develop and… more
- Merck & Co. (Rahway, NJ)
- …and compliance of our company's product portfolio across the internal and external networksThe candidate is expected to build inclusive, collaborative ... partnerships with internal and external stakeholders, such as packaging and manufacturing...platform stewardship.- This includes above site support for significant investigations , complaints monitoring and rapid response activities. Manage the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and process support installations.Assist in maintaining reliability and compliance through preventive maintenance programs and equipment monitoring.Learn to ... and SOPs within the Quality Management System.Participate in root cause investigations , CAPAs, and change controls by gathering data, preparing documentation, and… more
- Merck & Co. (Rahway, NJ)
- …that provides substantial technical responsibility and leadership of internal and external work.The Scientist, Engineering position leverages scientific/technical ... will be expected to exhibit a mindset of safety and quality compliance , which will include following current Good Manufacturing Practices (cGMPs), and participating… more
- Merck & Co. (Rahway, NJ)
- …the successful completion of projects. This includes technical support to the internal and external manufacturing sites as well as Third Party Logistics providers ... systems.-The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and 3rd party logistics… more
- Repligen (Waltham, MA)
- …Notifications (SCNs)Evaluate and manage Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate ... growing Supplier Quality team. You will a key role in ensuring the quality, compliance , and performance of Repligen's global supplier base. This is an opportunity to… more
