- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, including relevant regulations and guidances (eg 21… more
- Merck & Co. (Rahway, NJ)
- …Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: ... Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min....liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Merck & Co. (Rahway, NJ)
- …review with clinical partners and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for all study product needs ... in critical non-pipeline activities. - Participate in Interactive Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for assigned studies .… more
- Merck & Co. (Rahway, NJ)
- …release of drug product across assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for all product s used within ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… more
- Merck & Co. (Rahway, NJ)
- …in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software ... to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such as master… more
- Novo Nordisk Inc. (Boston, MA)
- …Nordisk within a specified geographic area, engaging with selected health systems , key academic centers, specialists, primary care providers, and other stakeholders. ... Management Assess and adapt sales and promotion strategies to align with health system account practices, care pathway decisions and managed care impact in the… more
- Merck & Co. (Rahway, NJ)
- …assigned studies such as IRT & Microsoft PowerApps. -Works directly in the SAP system to ensure a robust and consolidated forecast for CFGs is maintained. --Report ... and clinical customer relationship management.-Technical Proficiency: familiarity with supply chain systems and software (eg SAP or Oracle) and demand planning… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Merck & Co. (Durham, NC)
- …CMMS system platforms and route engineering change requests through CMMS system .Expand knowledge into other systems , capable of managing change in the ... or finished pharmaceutical environmentExperience in automation and manufacturing execution systems (MES), process modeling and process improvement.Mechanical functionality and… more
- Novo Nordisk Inc. (Durham, NC)
- … systems and associated applications required Proven expertise in system interfacing and integration required Experience in Project Management, Batch Reporting, ... - effective day one Guaranteed 8% 401K contribution plus individual company match option Family Focused Benefits including 14 weeks paid parental & 6 weeks paid … 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 ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Merck & Co. (Upper Gwynedd, PA)
- …Software Development, Software Development Life Cycle (SDLC), Strategic Initiative, System Designs, Systems Integration, Tensorflow, Testing, Version Control, ... (eg, MLFlow, Docker, SageMaker or other cloud-based solutions).Familiarity with version control systems (eg, Git), GitHub actions and CI/CD processes to manage model… more
- Merck & Co. (Durham, NC)
- …Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved vendors for calibrations not performed by site ... to ensure appropriate instrument turnover to site.Expand knowledge into other systems , capable of managing change in the pursuit of continuous improvement.Support… more
- AUROBINDO (Durham, NC)
- …start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, ... and producing reports, as needed. (currently utilizing Paylocity as our HRIS system )Assist in talent acquisition and recruitment processes by creating and posting… more
- Merck & Co. (Durham, NC)
- …of the Site Automation team responsible for the assigned process control systems in support of manufacturing operations located in Durham, NC.This Individual will ... and engineering groups.- Supports a spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new… more
- Merck & Co. (Rahway, NJ)
- …from internal teams and provide training on vendor management and e-billing systems . Assist in firm rate negotiations, matter budgeting, and billing issues. Foster ... support and training for legal staff and outside counsel on the eBilling system and developing resources for new users. Implement solutions to streamline billing… more
- Merck & Co. (Durham, NC)
- …Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved vendors for calibrations not performed by site ... to ensure appropriate instrument turnover to site.Expand knowledge into other systems , capable of managing change in the pursuit of continuous improvement.Lead… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processingPrepares and maintains training lab, materials… more
