- Tris Pharma (Monmouth Junction, NJ)
- …standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event, ... product quality complaintsEngages in activities to continuously assess and improve quality systems by identifying and proactively resolving quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technology solutions within RD Finance- Manage projects that affect RD financial systems and processes- Perform system configuration related to finance ... a key change agent and innovator for R&D financial systems and data analytics. Identifies R&D Financial Planning &...technology solutions to address those needs. Applies in depth system and business process knowledge in support of initiatives… more
- Aequor (Bothell, WA)
- … documentation practices. PURPOSE AND SCOPE OF POSITION:The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation ... of computer system validation efforts for new system implementations and changes to existing systems .DUTIES...and audit trail / user access reviews), coordinating with system owners and Quality in accordance with… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …management, and quality risk management and support strategic changes to the Quality Management System (QMS) to ensure compliance with GxP regulations and ... industry best practices. System Validation Oversight: Oversee all aspects of computerized ...Deep expertise in the implementation and validation of IT systems using best quality practices in compliance… more
- Merck & Co. (Durham, NC)
- …in a fast-paced team environment to meet critical production timelines.Preferred Quality Control laboratory settingsKnowledge of Laboratory systems (GLIMS, ... Job Description Job Description: Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …many stakeholders.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Require minimal direction to complete ... multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the ...Quality Project Management and Strategyas part of the Quality team based in Raritan, NJ. Role OverviewThe Associate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … system validation or qualification of global GxP and Non-GxP computer systems .Create and review various validation documentation such as Validation Plans, ... Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review… more
- Merck & Co. (Durham, NC)
- …washers, autoclaves, tube welders/sealers, WFI stills, Clean steam generation) Automated Systems (eg Distributed Control System (DCS), Programmable Logic ... Controllers (PLC), robotics, Building Automation System (BAS)) Clean-In-Place (CIP) Systems Maintenance Equipment (eg tools and calibration equipment) Support to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …(GDP).Perform tasks on time in a manner consistent with quality systems , cGMP, and Learning Management System (LMS) requirements.Identify, develop, and ... must have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management … more
- Aequor (West Greenwich, RI)
- …but is not limited to, the maintenance of training records, laboratory documentation , written procedures, building monitoring systems and laboratory notebooks. ... supervision, this position will perform routine procedures to support testing within Quality Control. Tasks may include but not limited to performing sample… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a Solutions Architect who supports the planning & definition, acquisition, design & system build, and testing phases of systems development of global informatics ... and immune disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the business functions of Daiichi Sankyo… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems engineering team. This role will require ... (Corrective and Preventive Actions) and CCs (Change Controls) within quality management systems . You will also write...and work instructions that are part of the QMS ( Quality Management System ).You combine the knowledge of… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... purpose of this position is to contribute to the establishment of all utilities systems for the OFP site Durham. Responsibilities include, but are not limited to,… more
- Merck & Co. (Durham, NC)
- …columns)- Support Equipment (eg washers, autoclaves, tube welders/sealers)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic ... and preventative maintenance (PM's) plans, as requested. Responsible for written documentation of activities. Responsible for SAP transactions and change control… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Change Control Program. Further, the Documentation Control Supervisor serves as the system owner for the Enterprise Quality Management System (EQMS). ... . This position will additionally serve as a final Quality Reviewer/Approver for internal documentation . The ...and three (3) to five (5) years in the Pharmaceutical Industry, preferably in a Quality Systems … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …developing high quality solutions based on Functional Design documents. Perform system customization and configuration work as needed to support new and existing ... role encompasses overseeing design, configuration, testing, and deployment to ensure these systems operate efficiently and accurately. The primary goal is to meet … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …curricula development experience desirable, including oversight and administration of validated electronic systems such as LMS or other quality management ... of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training...and in close collaboration with the QA Training and Documentation management team. This position will take direction from… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... refrigeration,pipefitting, and millwright activities associated with the related mechanical systems , utilities, andprocess equipmentPerform minor upgrades and installations of… more
- Merck & Co. (Rahway, NJ)
- …desires with technology capabilities.Develop and maintain product materials, including training documentation , SDLC documentation , and product guides, to ensure ... maximizing value for investments.Organizational Change Management: Demonstrate and drive high- quality change management practices with clients and stakeholders while… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... Functions Training: Maintain high state of knowledge of the Safety database systems and reporting tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines and… more
