- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Maintenance Specialist I (3rd shift) as part of the Facilities & Engineering team based in Raritan, NJ. Role OverviewThis position will ... be responsible for maintenance support and mechanical system operations for cGMP Clinical...upgrades and installations of facilities and systemsPerform on-site equipment maintenance and critical utilities maintenance operations, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendors and the global CSPV team. This position assists in the monthly maintenance and reconciliation. This position is expected to handle ICSR issues in accordance ... as well as creating/retrieving case file folders. Reconciliation: Performs monthly maintenance and reconciliation of trackers for safety data exchanged with license… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position ... drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the CDR/AP system(s) including the areas of study setup, creation and maintenance of standard hierarchy structures and user access controls for all clinical ... administration activities within the CDR system may include the creation & maintenance of standardized and custom user roles and data hierarchies, assignment of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors).Lead respective ... and collaborate with respective regional leads to align and incorporate system maintenance controls.Collaborate across each functional area of HR working with COEs,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plantManages multiple and complex CQV ... projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required remediation efforts and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMOs with respect to the facility, equipment lab instruments, engineering, maintenance , computerized systems and validation activities which complies with GMP ... guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.Drug Product Management: Supports technically the operational activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMOs with respect to the facility, equipment lab instruments, engineering, maintenance , computerized systems and validation activities which complies with GMP ... guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.Drug Product Management: Supports technically the operational activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …expert for Compliance & Training systemsKnowledge of LMS systemSupports the maintenance and reporting of quality training metricsJob duties performed routinely ... require exposure to and handling of biological materials and hazardous chemicalsJob duties include operating an industrial vehicle; Ability to lift a minimum of 50 lbs and stand for a long period of timeDistance visual acuity of at least 20/30 (Snellen) in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …impact assessments and implementation of changes as required.Lead development and maintenance of RBQM standards such as guiding principles, risk, quality tolerance ... limit (QTL) libraries, and critical-to-quality factors.Lead RBQM Center of Excellence for central statistical monitoring topics, ensure optimal utilization of the cross functional SMEs to embed RBQM across portfolio of studies and ensure adoption.Engage with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance , Supply Chain and PlanningApprove the change in scope or ... level of an investigationPerform timely escalations of potential significant quality issues to managementEscalate to management about issues delaying product release or investigation closureMonitor timely completion of batch release related impact… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data quality and security, supported by regular audits, data maintenance and continuous improvement processes.Project Management: Effective management of timelines ... and deliverables, along with experience in Agile and Waterfall methodologies, is essential. Preferred SkillsPractical experience in SuccessFactors as a functional consultant or configurator or SuccessFactors Certification would be highly regarded… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the GCL, if applicableDelivers all relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical ... benefit-risk assessments for license renewals, responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDLContributes from a medical strategy standpoint to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans, including training and support models, to ensure ongoing system maintenance and performance. Qualifications: Successful candidates will be able to meet ... the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree Bachelor's degree in computer science, information systems or related field required Experience… more
- HEPCO, Inc. (Middlebush, NJ)
- …a valid driver's license, and a clean driving record Responsible for maintenance and fees of the vehicle Develop management tools for monitoring project ... progress and performance Present program details for recruitment, training, and communication purposes Participate in internal and external training sessions Required Skills Must have reliable transportation, a valid driver's license, and a clean driving… more
- HEPCO, Inc. (Middlebush, NJ)
- …transportation for site visits throughout New Jersey, with responsibility for vehicle maintenance and fees. Valid driver's license and a clean driving record. ... Aptitude for understanding building science, including mechanical, electrical, and/or weatherization technologies across various building types. Strong computer and record-keeping skills, with proficiency in MS Office and Customer Relationship Management (CRM)… more
- Merck & Co. (Rahway, NJ)
- …(Piping and Instrumentation Diagrams), electrical drawings, and troubleshooting & maintenance techniques. In addition to technical expertise, this individual will ... computer skills including MS office, User Specifications for equipment. General maintenance of processing equipment.Oversee routine and preventive maintenance on… more
- Tris Pharma (Monmouth Junction, NJ)
- …in ensuring efficient packaging of goods by performing packaging equipment maintenance including, but not limited to: troubleshooting, repair, upgrade, preventive ... maintenance (PM), etc. on various types of packaging equipment...& Responsibilities: Responsible for all aspects of Packaging equipment maintenance in accordance with company policies, SOPs, cGMPs and… more
- Genmab (Plainsboro, NJ)
- …planning tasks, activities, and deliverablesGlobal Clinical Drug Supply:Support development and maintenance of SOPs for the Global Clinical Drug Supply Operation ... SME knowledge supportCoach and mentor colleagues during onboarding and maintenance of trainingResponsible for oversight and resolution of deviations, CAPAs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of routine office duties involving typing, invoicing, record and file maintenance , data entry, meeting/travel arrangements, planning and execution of either on ... or offsite department meetings, processing expense reports, department event planning (eg off sites, team building, group meetings), running reports, vendor management etc. Physical Requirements 0-10% overnight travel required. This role is required to be in… more
