- Aequor (Bothell, WA)
- …IATA/DOT 19 CFR Certification. Receipt, inspection and quarantining of GMP raw materials and manufacturing aides. Material requisition fulfillment and delivery ... Program, track and download temperature monitors as required by the business. Inventory control and maintenance of drug substance, raw materials , disposables and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director, Device System - Design Control plays a pivotal role in combination product development (both design and process), commercialization and ... lifecycle management. This person leads the design control team to ensure achievement of high-quality products and robust manufacturing processes.- This position… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the Global Manufacturing & Supply (GMS) data governance process, from material creation to consumption across Warehouse, Materials Planning, Work Centers, ... Master Data Governance Sr. Specialist with a specific focus on Materials orchestration throughout the End-to-End Manufacturing & Supply lifecycle. This role… more
- Merck & Co. (Rahway, NJ)
- …supports execution of analytical methodologies to characterize and release raw materials , package components, clinical drug substance, and clinical drug product for ... you will work with the GMP Analytical and Raw Materials teams on strategies associated with Operational Excellence. The...parts of the AR&D organization in aspects of quality control and compliance. Your main responsibilities will include: -… more
- Merck & Co. (Rahway, NJ)
- …learn and contribute.Education Minimum Requirement: -Ph.D. in Chemical Engineering, Material Science, Chemistry, Pharmaceutics, or Related Discipline -MS in Chemical ... Engineering, Material Science, Chemistry, Pharmaceutics, or Related DisciplineRequired Experience and Skills: -A PhD with 0+ years of experience or a MS with 5+… more
- Novo Nordisk Inc. (Boulder, CO)
- …patients Work effectively across all departments, such as Quality Assurance/ Control , Chemical Development, Program Management, Regulatory, Quality Control , ... or other controlled documents as needed Manage timelines, production plans, and material requirements Ensure the effective use of material , equipment, and… more
- Merck & Co. (Rahway, NJ)
- …Program Manager will be involved with the creation and execution of Quality Control and User Acceptance Testing procedures for electronic data capture systems, and ... person may participate in the development of job specific training material , with MPI, and deliver training material as needed to the staff.May be assigned to a… more
- Merck & Co. (Rahway, NJ)
- …such as residual and PCR-based assays).Strong background in analytical control strategy development and execution.Demonstrated ability to develop talent through ... of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.A strong team player… more
- Merck & Co. (Rahway, NJ)
- …clinical drug substance and product and their stability tests, raw materials /excipients, and packaging components for our research pipeline.- This research ... It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with responsibilities for supervising the operation and workflow of the quality control laboratories in support of cell therapy manufacturing. This includes hiring, ... plans for direct reports.Be responsible for the completion of QC raw material /utility, in-process, or final product samples testing related to the manufacturing of… more
- Merck & Co. (Durham, NC)
- …SAP PM transactions and calibration activities including creating change control records and non-maintenance notifications. Actively supports, participates and ... WFI stills, Clean steam generation)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics, Building Automation… more
- Merck & Co. (Durham, NC)
- …SAP PM transactions and calibration activities including creating change control records and non-maintenance notifications. Actively supports, participates and ... (eg washers, autoclaves, tube welders/sealers)- Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC), robotics)-Clean-In-Place (CIP)… more
- Aequor (Devers, TX)
- …decision-making, and building relationships.Knowledge of quality processes, including material disposition, change control , product complaints, deviations, ... conclusions consistent with Quality Risk Management principles.Knowledge of quality processes, change control , product complaints, deviations, investigations, and CAPA… more
- Merck & Co. (Rahway, NJ)
- …upstream or downstream bioprocessingIntegrate unit operations with relevant process control and monitoring platformsCollaborate across BPR&D, process analytics, and ... transfer to clinical or commercial manufacturing facilitiesKnowledge of process control and workflow automation tools Strong foundation in statistical analysis,… more
- Merck & Co. (Rahway, NJ)
- …of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.Adaptability and ... and advanced in situ analytics for process monitoring and control .Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise. Follow all design work and integration testing protocols, change control procedures, standards, procedures and practices in performing required work. ... Analysis, CATS etc. SAP SCM modules: Sales and Distribution, Material Management, Production Planning, Logistics, Sample Allocation Management Functionality, Master… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …and wet tissues), as well as retention samples of test and control articles, as required. Receipt of non-study specific records (validation/qualification studies, ... study. Ensures the appropriate inventory and submission forms are submitted with the materials to be archived. Assigns a storage location in the various archive… more
- Merck & Co. (Rahway, NJ)
- …systemsKnowledge of Quality by Design, Process Characterization and Control Strategy development#BPRD #PRD #EligibleforERPCurrent Employees apply HERE Current ... Requirements: 10%Flexible Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:NoHazardous Material (s):n/aJob Posting End Date:12/27/2024 *A job posting is effective… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …clinical and educational initiatives by coordinating company resources (eg, counterparts, materials , information, initiatives, etc.) to ensure an aligned approach to ... Nordisk Sales/Marketing Departments to maximize appropriate and effective use of selling materials and product information Develop and maintain a mastery of product… more
- Merck & Co. (Rahway, NJ)
- …as data stewards responsible for qualification, data analysis, creation, modification and change control for SAP BPC. The LPT COE Sr. Specialist is responsible for ... RegularRelocation:VISA Sponsorship: Travel Requirements: Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material (s):Job Posting End Date:12/6/2024 *A job posting is effective… more
