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Develop detailed project plans including resource plan, communication plan, and timeline of activities required for success. Runs meetings as required, with clear agendas, documents meeting outcomes and communicates tasks and timelines to internal and external team members. Develop project budgets, including required labor, and manage project within budget constraints. He
Posted 17 days ago
Supports the development or update of product Risk Management Plan to proactively assess product risks and mitigate potential harm/hazards Conducts and oversees literature search to monitor product performance and safety Helps the development of post market safety surveillance reports Assist the Medical Safety Officer to assess the patient impact and developing health haz
Posted 27 days ago
Performs daily preventive and demand maintenance tasks for production machinery or facilities. Addresses maintenance demands to meet production schedules. Reads and interprets equipment manuals, procedures, and drawings to perform required maintenance. Performs root cause analysis, communicates recommendations, and implements solutions that prevent reoccurrence. Orders pa
Posted 17 days ago
Execute manufacturing or manufacturing support processes according to standard operating procedures and current curriculum. Support schedule adjustments to meet production, material receipt and shipping requirements. Work with Shift Leader//Team Leader to review departmental production schedules, work orders and related information to ensure materials are available for pr
Posted 28 days ago
Evaluate current processes, equipment and skills to enable an improved calibration process across Assay Manufacturing including reviews and approves calibration procedures to ensure technically defensible standards, methods, and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of the equipment, instruments and processes are maintai
Posted 17 days ago
Manage and assist in the development of study related documents such as protocols, informed consent forms, training materials, site feasibility questionnaires and site qualification/selection criteria. Assure compliance to study protocols. Serve as a resource to site coordinators, investigators, and other staff members regarding the planning and execution of the study, ma
Posted 28 days ago
The assessment of deposition and coating technologies for microfluidic, liquid cell, and layered film devices and the subsequent development of the technology for transfer to manufacturing. The definition and development of manufacturing conversion processes such as surface functionalization and material bonding. Assess assay device function, define root cause for failure
Posted 17 days ago
Responsible for interpreting regulatory requirements, determining strategies and identify risks in support of Transfusion Medicine project teams. Interact with US FDA and/ or International regulatory personnel to define submission content, expedite pending applications, and resolve regulatory matters. Prepare submissions to meet regulatory agency expectations for BLA and/
Posted 28 days ago
Provide production support to manufacturing which will result in lowering product cost, improving labor performance, cycle times, eliminating bottlenecks and improving throughput levels. Work with Manufacturing support personnel as a technical lead to troubleshoot and repair electrical and mechanical process systems. Work activities must be documented via a Computerized M
Posted 18 days ago
Partner with NA L&D & Global L&D leadership team and North America Marketing on the strategy, creation, execution, and effectiveness of 18 24 month product training calendar that aligns to NA Commercial goals Responsible forunderstanding company training philosophy and confirm all company activities are developed and designed with operations in mind Responsible for the de
Posted 29 days ago
Provide production support to manufacturing which will result in lowering product cost, improving labor performance, cycle times, eliminating bottlenecks and improving throughput levels. Work with Manufacturing support personnel as a technical lead to troubleshoot and repair electrical and mechanical process systems. Work activities must be documented via a Computerized M
Posted 18 days ago
Oversee day to day Manufacturing schedule activities as required to support Operations. Participate and collaborate with Materials Management, Facilities, Quality and Engineering leaders to identify potential areas of process and product variability, addresses Non Conformances (NC's), investigations, root causes, and implements improvements. Provide Voice of Customer (VOC
Posted 29 days ago
Troubleshoots and repairs equipment used in manufacturing and packaging areas. Reads and interprets equipment manuals and work orders to perform required maintenance and service. Performs routine and non routine preventative maintenance in accordance with approved methods and documentation. Applies safety procedures to all work. Documents all work activities via CMMS. Fle
Posted 18 days ago
We are seeking a qualified individual who has experience installing, operating, maintaining, repairing and modifying electromechanical equipment, preferably in the field. Troubleshoot technical problems and systems issues. Determine technical solution in accordance with product and customer specifications, and recommends actions to company or customer representatives for
Posted 29 days ago
Troubleshoots and repairs equipment used in manufacturing and packaging areas. Reads and interprets equipment manuals and work orders to perform required maintenance and service. Performs routine and non routine preventative maintenance in accordance with approved methods and documentation. Applies safety procedures to all work. Documents all work activities via CMMS. Fle
Posted 18 days ago
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