- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Sr . QC Analyst (Third Shift) as part of the Quality team based in Raritan, ... NJ. Role Overview The Sr . QC Analyst, CAR-T Manufacturing is an exempt level...applicable procedures, standards and GMP regulations Work with Process Development team, Quality and Operations organization to successfully transfer… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking an Operations Supervisor / Sr . Operations Supervisor (2nd shift) as part of the Technical Operations team ... team, in a manner consistent with safety policies, quality systems , and cGMP requirements. Support manufacturing investigations, create/revise operational… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …improve data practices for operational, reporting and analysis needs - Inclusive of development of processes, control and best business practices around data ... the treatment of multiple myeloma. Legend Biotech is seeking a Master Data Governance Sr . Specialist as part of the Technical Operations team based in Raritan, NJ.… more
- Catalent (St. Petersburg, FL)
- …The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, and Change Control .II. Basic Function: ... Standard Operating Procedures through the periodic inspections and monitoring of process controls in all applicable areas of the manufacturing operation. The … more
- Merck & Co. (Rahway, NJ)
- …compliance with company requirements and regulations are delivered and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial ... Management (RCQM), and in collaboration with the Clinical Research Director(s), the Sr CCQM Lead establishes and/or - local clinical Quality Management System… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …installation, engineering start-up, documentation and validation activities of new and modified control systems Participates in the development and ... the design, implementation, start-up and troubleshooting of automation and plant floor control systems . Under close supervision is responsible for the design… more
- Merck & Co. (Rahway, NJ)
- …methods as needed in tech transfer or lifecycle.Experience with medical device development with understanding of Design Controls (21 CFR 820.30)Familiarity with ... Job DescriptionOur company's Device Development (DD) Team is seeking a hands-on analytical...selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA's) for all finished product performance test… more
- Merck & Co. (Durham, NC)
- …Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development , Technical Services, Utilities and Validation. --Summary, Focus ... and PurposeThe Senior Maintenance Technician - Vaccine Manufacturing Facility is responsible...new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the… more
- Merck & Co. (Durham, NC)
- … in relation to air handling unit maintenance, operations, and reliability)Automated systems (eg, Distributed Control System , Programmable Logic ... dehumidification system room pressure controlsIndustrial experience involving utility system generation, distribution and control and strong knowledge of… more
- Merck & Co. (Durham, NC)
- …(eg 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
- Merck & Co. (Rahway, NJ)
- …Machine Learning (ML) or Artificial Intelligence (AI) Experience with the SDLC ( system development lifecycle) NOTICE FOR INTERNAL APPLICANTS In accordance with ... (CLIC) end-users Collaborates with internal and external organizations in the development and integration of literature-related systems and information When… more
- Aequor (Devers, TX)
- …Engineering (Maintenance and Metrology activities), Supply Chain/Warehouse, Laboratories (Quality Control and Process Development ), or Cell Therapy ... audits EHS program implementation Job Description: Environmental, Health, and Safety Senior Specialist (EHS Senior Specialist) Onsite role--Local candidates only… more
- Merck & Co. (Rahway, NJ)
- …his/her knowledge of product design and development ; manufacturing process development , qualification, and validation; and, design control and risk ... (eg engineering design, engineering analysis and testing, medical device design controls , risk management, test method/fixture development , design verification… more
- Merck & Co. (Rahway, NJ)
- …, Software Development Life Cycle (SDLC), Solution Architecture, System Designs, Systems Integration, TestingPreferred Skills:Job Posting End Date08/22/2024 ... product owners to deliver solutions using Agile methodologies.Collaborate with systems engineers, software engineers, data services, architecture, test engineers,… more
- Eisai, Inc (Nutley, NJ)
- … controls . Review CAPA and verification of CAPAs of system audits. Support health authority audits/inspections for inspection readiness. Requirements Bachelor's ... and oncology, with a strong emphasis on research and development . Our history includes the development of...from you. Essential Functions QA approver for internal computer system validation efforts. Act as liaison to the business… more
- Merck & Co. (Rahway, NJ)
- …a dynamic team that offers a flexible work environment, leadership development programs, travel opportunities and workplace inclusion.We are a leading pharmaceutical ... company committed to improving health through innovative research, development and production of medicines. With a strong emphasis on ethical practices, employee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …shipment delays and is able to communicate the issues and support resolution development .Support IRT design for control of drug dispensing and inventory ... position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and remediating User issues. Provide support across all areas of CRM system development lifecycle (SDLC) including creating training documentation for all ... for the administration and operational support of Daiichi Sankyo's Veeva CRM system within IT. They'll collaborate with various sales and marketing customers to… more
- Catalent (St. Petersburg, FL)
- …site. The Department has the responsibility for Quality aspects related to Quality Systems , Finished Product Batch Release, Change Control , Client interface, Lab ... of focus. Position requires partnership with other functional areas (eg Product Development , Operations, Customer Service, Validation, Quality Control , etc.) to… more
- Tris Pharma (Monmouth Junction, NJ)
- …directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, ... privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that address unmet patient needs.… more