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This position performs primary notification and is a consolidation point for receiving and processing basic complaint investigation activities. The position ensures timely and accurate investigation of customer complaints to help ensure Fresenius Kabi complies with all regulatory obligations and meets the customers' needs. Responsibilities Perform complaint investigation
Posted 27 days ago
Fresenius Kabi USA, LLC
- Buffalo, NY / Rochester, NY / Baltimore, MD / 6 more...
The Plasma Services Consultant is responsible for providing technical and operator l product and sales support for customer organizations within an assigned territory in US. Act as key customer liaison and consultant managing both customer and company needs. Assist in process and operational improvements within a customer center and ensures that customers are properly tra
Posted 1 month ago
Fresenius Kabi USA, LLC
- Lake Zurich, IL / Albuquerque, NM / Buffalo, NY / 49 more...
The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next generation technology for cellular therapy. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively
Posted 6 days ago
POSITION SUMMARY Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in responsible to deviations noted. Assures compliance to SOP's and cGMP's. Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas. Responsibilities
Posted 16 days ago
This position performs primary notification and is a consolidation point for receiving and processing basic complaint investigation activities. The position ensures timely and accurate investigation of customer complaints to help Fresenius Kabi comply with all regulatory obligations while meeting the customers' needs. Responsibilities Capture all complaint information and
Posted 30 days ago
Fresenius Kabi USA, LLC
- North Andover, MA / Boston, MA / Manchester, NH
The Mechanical Engineer, Control Systems will be responsible for MATLAB development for pneumatics systems. Works on the design and development of the control systems embedded in the Ivenix infusion pump. This experienced engineering position, under minimal supervision participates in designing, coding, documenting, testing and maintenance of real time embedded software a
Posted 1 month ago
A Scientist II in Quality control displays an advanced knowledge in chromatographic techniques and instrumentation and guides others in troubleshooting instrumentation and routine test methods. A Scientist II participates in the mentoring and training of less experienced analysts in the group. Responsibilities Performs accurate routing and non routing testing utilizing in
Posted 6 days ago
POSITION SUMMARY Responsible for the accurate weighing, checking and verification when mixing specific chemical compounds for product formulation. Performs monitoring of mixing and ancillary support equipment throughout formulation and filling and executes calibrations and preventive maintenance activities. Routinely complies with cGMP's, departmental SOP's and company po
Posted 16 days ago
Under direct supervision, provide clerical and administrative support for documentation system under cGMP and support the Quality System. Issue and control documents according to established procedures. Administer document routing and review process. Research and collate file records as needed. May also operate a desktop computer using word processing software. Fill docum
Posted 30 days ago
The Principle Electrical Engineer is responsible for product design, product development, and product support of Automated Blood Technology medical devices. Responsibilities Design and develop new or improved electronic sub assemblies for medical devices. Design activities include analog and digital circuit design, schematic capture, printed circuit board layout, componen
Posted 6 days ago
Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t
Posted 17 days ago
The Manufacturing Technician II is responsible for effectively troubleshooting the cause of manufacturing non conformances of in process medical devices and making the required repair in accordance with manufacturing procedures. The position includes performing testing, sorting, and rework of non conforming parts found in manufacturing or at receiving inspection. Other re
Posted 1 month ago
The Director for Strategy & Business Development will serve as a contributing member within Transfusion Medicine & Cell Therapies division, focusing on the Fresenius Kabi Cell and Gene Therapy (C>) portfolio. The position reports to the Director of Marketing (Cell & Gene Therapies). The candidate will work closely with R&D, Commercial, and Regulatory to establish, evolv
Posted 6 days ago
Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t
Posted 17 days ago
The Technology Transfer Leader is a Manufacturing Operations subject matter expert that will actively collaborate with quality, regulatory, manufacturing, engineering and global I&D teams. The position is responsible for coordinating the transfer and implementation of projects and technology from development groups and customers to the plant manufacturing site. The incumb
Posted 10 days ago
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