- Merck & Co. (Rahway, NJ)
- …continue advancing medical innovation and improve lives.SPECIALIST (P-2), -Audit and Assurance ServicesOur Company Corporate Audit and Assurance Services' ... is to provide value-added independent and risk based audit and assurance services.Position Responsibilities:Under the direction of the Client Audit Director ("CAD")… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations.Collaborate with Quality Assurance , ... various QC Microbiology department projects, supporting laboratory investigations, and support and track all process improvement projects.Key Responsibilities … more
- Merck & Co. (Rahway, NJ)
- …play a pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors and ... metrics for the team to drive excellence.Device Quality OversightOversee the quality assurance of complex devices, such as auto-injectors and other complex drug… more
- Eisai, Inc (Nutley, NJ)
- …Executive level.Excellent Business/customer-facing experience.Strong knowledge of legal, technical and assurance principles relating to information security and ... commercial requirements that govern the organization's technology systems and information assets.Purpose of role:Oversee IT compliance initiatives (strategic and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsible to support PV Quality System audits at our company's Animal Health own sites/entities, CROs and system audits. Support to monitor all ... externally with CRO's, laboratories, contactors, and external business partnersPerform and Support PV audits as required.Review and Approve Corrective and Preventive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This ... complex projects, provide status reports, and coordinate with cross-functional departments. Support Document Management system users with workflow handling and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the operation and workflow of the quality control laboratories in support of cell therapy manufacturing. This includes hiring, development and performance ... to cGMP facility to manufacture products.Work with cross-functional departments to support the manufacturing of autologous CAR-T products for clinical and commercial… more
- Merck & Co. (North Wales, PA)
- …mentoring and coaching to Sr. Scientist and Assoc Principal scientist in support of their assigned projects. Position Description- The Principal Scientist / Director ... in product in-license/due diligence review, product divestment and product withdrawal. Support new technology development.Demonstrate an understanding of regulatory affairs… more
- Merck & Co. (Rahway, NJ)
- …clinical trials to world-wide regulatory application submissions and post marketing support .The incumbant is responsible for the design and maintenance of ... statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is a key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …providing quality oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This ... instructions.Develop positive relationship with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human… more
- Merck & Co. (North Wales, PA)
- …supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance (QA) organizations within our Research & Development Division . Key ... responsibilities include: Provide financial planning, forecasting and analytical support to our Research & Development Division, Global Regulatory Affairs & Clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …over process improvement projects within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. ... This role will oversee, lead and support quality activities for continuous improvement efforts, Quality site...to complete tasks, knows how to get resources and information from established internal contacts; consult with supervisor for… more
- Aequor (Swiftwater, MN)
- …authoring of CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that support site registrations, ... Regulatory CMC Specialist will ensure Regulatory compliance by providing support to batch release by checking submission/approvals, ensuring permanent… more
- Merck & Co. (North Wales, PA)
- …clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible for the design and maintenance of ... statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …over process improvement projects within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. ... This role will support quality activities for continuous improvement efforts, site escalations,...to complete tasks, knows how to get resources and information from established internal contacts; escalates to management when… more
- Merck & Co. (Durham, NC)
- …users), disaster recovery plans, business continuity plans). Review processes and support documentary evidence to verify that compliance activities related to ... computerized systems are in place and effective. Support regulatory inspection and audit activities as needed. Conduct review of audit or inspection reports,… more
- BioAgilytix (Durham, NC)
- …comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information Management System (LIMS). This onsite role requires close ... the successful delivery of the LIMS project, from planning to post-implementation support , with a strong focus on regulatory compliance and lab efficiency.Key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with Operations Department and other supporting groups (Engineering, Quality Control, Quality Assurance and other as applicable) to support the execution of ... team based in Raritan, NJ. Role OverviewThe Process Validation Technician will support the validation department in establishing a robust and sustainable Aseptic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies and practices. Additionally, the Lead collaborate with business teams, help support in the creation of business cases and the preparation of Kessai ... systems and solutions meet the required quality standards, collaborate with quality assurance teams to ensure that all non-regulated systems are thoroughly tested… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. ... and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing… more
