- ValSource, Inc. (Rahway, NJ)
- …ValSource is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a ... ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams of… more
- Merck & Co. (Rahway, NJ)
- …benefits realization Lead cross-functional delivery programs (software, controls , integrations, data /analytics, automation vendors), ensuring disciplined ... controls ; translate shopfloor realities into robust digital and control solutions. Drive architecture-level decisions and integration approaches across MES/MOM,… more
- Merck & Co. (Rahway, NJ)
- …improvementRepresent automation in capital projects, embedding OT/IT architecture, cybersecurity, data integrity, and validation requirements in project scope ... (FLEx) and new capital builds, including automation lifecycle management, data /analytics, and site representation on capital projects.- Some off-shift work… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our ... including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of design verification strategies, and… more
- Merck & Co. (Rahway, NJ)
- …Experience.Required Skills: Accounting, Accounting, Adaptability, Asset Accounting, Audit Internal Controls , Contract Audits, Data Analysis, Financial Advising, ... both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will...our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management… more
- Merck & Co. (Rahway, NJ)
- …MS Office Suite (Outlook, Word, Excel and SharePoint) and Adobe Acrobat ProStrong project management skills, including the ability to lead and oversee complex ... annuities ensuring that all maintenance payments are made on time, data verification checks are performed and discrepancies resolvedOversee IP docketing system… more
- Cipla (Fall River, MA)
- …manufacturing/packaging record. Review of engineering records such as temperature and humidity data calibration and PM records, pest control records and ... the equipment and associated controls during the batch run. Act as quality lead for all shop floor questions / concerns. Backup for shop floor QA Associates.… more
- Merck & Co. (Rahway, NJ)
- …challenges and influence across the enterprisePreferred Experience and Skills: Project management, including change control and equipment qualificationSAP ... Requests, People Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory Compliance, Regulatory… more
- Insmed Incorporated (San Diego, CA)
- …Manage and provide oversight on multiple projects simultaneously. Coordinate and lead validation activities with internal stakeholders and project team ... review and approval in Veeva etc. This role will participate in on site Change Control CAB meetings as the CSV lead . Who You Are: Position Requirements (Required… more
- Insmed Incorporated (NJ)
- …specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical/Manufacturing systems. Project lead experience preferred.Strong experience in Clinical Study ... management and remain in a validated state (eg SDLC, IT Change Control ) per associated SOPs, regulatory and security requirements. \tEnsure compliance and… more
- Merck & Co. (Rahway, NJ)
- …perform or coordinate routine and specialized audits of batch documentation, data , information, procedures, equipment and systems, and/or facilities to ensure ... are not restricted to:Advise supported areas on requirements for all assigned project responsibilities as related to quality and our company's standards and… more
- Cipla (Fall River, MA)
- …operating conditions. Review of engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor ... Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab and follow detailed documentation procedures to deliver the… more
- Cipla (Fall River, MA)
- …is responsible for the creation and revision of new and existing GMP, project handle, qualification & validation documents preparation and execution. In this role ... leads and manages projects to implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends… more
- Merck & Co. (NC)
- … Project management Experience involving utility system generation, distribution and control are preferred. Lead in the identification and implementation of ... management, troubleshooting and resolving manufacturing anomalies Minimum two years of project management experience with the ability to multi-task - Working… more
- TYLin (Newark, NJ)
- …managing configuration, workflows, permissions, and reporting. + Develop and enforce document control procedures and project controls standards to ensure ... and stakeholders. **Responsibilities & Qualifications** **What You'll Do** + Lead and manage the document controls program...decision-making. **What We're Looking For** + Significant experience in project controls and document control … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and innovate signal ... contact and support all signal management activities. They will lead the safety signal governance and develop, or update...maintenance of signal tool and support tasks of change control , training material update, and end user support or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical ... monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met. Lead the process… more
- Merck & Co. (Durham, NC)
- …raw materials, intermediates, and finished products.This role is within a capital project start-up in Durham, North Carolina. The new facility will include ... complying with current Good Manufacturing Practices in the form of project management and ultimately shop floor leadership.-Key Responsibilities for a Drug… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.Conceptualize, plan, and execute… more
- Insmed Incorporated (NJ)
- …command of the Systems Development Life Cycle (SDLC) processSolid understanding of Data Structure, Controls and End-to-End FlowExperience in Integrating Oracle ... We are looking for a driven, results-oriented leader to lead the effort in building Insmed' s next generation...the integration of acquisitions. This support may include mapping data , data conversions, system configuration, and business… more
