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The Vice President (VP) of Quality Assurance (QA) is a senior leader overseeing QA functions at our Holly Springs site. This pivotal role ensures compliance with regulatory standards, drives quality initiatives, and safeguards product and process integrity. Responsibilities include strategic planning, team leadership, and cross-department collaboration to promote quality excellence.
You will develop and implement the QA strategy for Holly Springs, working closely with the site Head and global leaders to ensure consistency. A key aspect of this role is overseeing the integration and adherence to the FDB quality system, ensuring robust operational standards. This position is also accountable for delivering quality programs and projects, ensuring staff engagement, and aligning execution with customer expectations, regulatory standards, and industry best practices.
As Vice President of QA, you are also a key member of the leadership team in Global QA Operations, playing an integral role in guiding global quality strategies. A significant responsibility includes participating in the development of the global QA strategy to enhance innovative, cross-corporate streamlined quality processes. This role will have approximately 5-10 direct reports and approximately 15-30 indirect reports.
The Scientist, Process Development, is a critical position responsible for development activities associated with cell therapy process development and design at Fujifilm Diosynth Biotechnologies, California (FDBC). This position provides hands-on support for all aspects of process development experimental design and execution, will be responsible for experimental process monitoring (data capturing), and process troubleshooting. This position will work closely with and/or under the direction of a Senior or Principal Process Development Scientist.
The Sr. Manager Quality Control (QC) Microbiology at Fujifilm Diosynth Biotechnologies California (FDBC) requires both leadership, technical, and business expertise. From a leadership perspective, the selected individual will need to lead, develop, and motivate staff. This requires a self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment. From a technical perspective, the selected individual will directly oversee QC Microbiology activities and deliverables to provide systems and processes to enable QC to complete department objectives. The Sr. Manager is responsible for ownership of FDBC Environmental Monitoring Program, and proactively identifies and implements industry standard methodologies for QC Microbiology. In addition, role model company core values of trust, delighting our customers, Gemba, and Genki.
Manufacturing Associate (1st Shift, Transducers) - Bothell, WA
This position is responsible for performing a variety of tasks associated with manufacturing diagnostic ultrasound transducers. Specific tasks may include some of the following:
The Field Service Technician – Level 3 will report to the Regional Support Manager and will be responsible for the service and maintenance of either multiple product lines that the service team supports or a high-speed inkjet product line. This level technician will demonstrate a full working knowledge of the product lines they support including theory of operation as well as the mechanics. This position will require travel throughout the United States.
The preferred location for this position is Maryland, USA.
The accomplished Senior Corporate Compliance Specialist will support FUJIFILM’s Corporate Compliance Program’s operations to ensure high ethical standards are observed and the compliance program is effective and efficient. The successful candidate will operate independently and with limited management oversight. The position will report to the Compliance Officer.
Who We Are
FUJIFILM Electronic Materials, U.S.A., Inc., is a global leader in chemical solutions which enable the semiconductor industry and the digital universe. We have an exciting opportunity at our Mesa, AZ facility for a LIMS Administrator!
With state-of-the-art manufacturing facilities in the U.S., Europe, Taiwan, China, Korea and Japan, local sales offices throughout the world and on-site applications support, FUJIFILM Electronic Materials supplies the world's top tier semiconductor manufacturers with a broad array of products and services used throughout the semiconductor manufacturing process.
The Role
The LIMS Administrator responsibilities include providing project management services to the laboratories and manufacturing in the areas of LIMS and SAP. They assist in the development and implementation of our existing Labware system, participates in application development, laboratory automation/optimization and supports our quality systems.
The Automation Engineer 3, DSM Upstream will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role focuses on supporting the delivery of DeltaV logic for Upstream process areas including Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest.
The Sr. Engineer, Quality Assurance is responsible for establishing and maintaining a robust and efficient Technology Transfer program at the Holly Springs, NC site. This position is responsible for ensuring the quality and compliance of initial Technology Transfer (TT) activities and supporting the continuous improvement and ongoing success of the TT lifecycle. This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation, and various Client functions to ensure Quality objectives and initiatives are effectively delivered in a phase compliant manner.
We are hiring a Liquid Packaging Technician. The Liquid Packaging Technician is responsible for Inspecting and labeling application for all filled product, case packaging of all sterile filled products into appropriate boxes, and bottle/vial preparation and staging.
1st Shift (5:00AM - 1:30PM)
This position is intended to oversee all technical aspects of Synapse product implementation, from solution validation phases through product go-live. The Project Engineer (PE) must have well rounded knowledge in all areas of medical informatics - IT infrastructure design and deployment, medical imaging industry expertise, and clinical environment workflow. In addition to technical expertise, PE's are also critical in HCUS's overall goals of delivering industry leading customer satisfaction, requiring excellent communication and verbal skills within project teams and externally with customers.
The Supply Chain Planner 3 role supports the project phase and operations of GMP Purchasing and Supply Chain Planning at FDBN to ensure that the right
materials are available at the right time, in the correct quantity to support process validations and GMP production. This role supports the materials
planning process and direct purchasing while liaising with both internal and external stakeholders on the status of material readiness. This role is
responsible for supporting the planning team and orchestrating associated tasks to start up, while transitioning into commercial operations, including, but
not limited, establishing standard operating procedure, reports, material plans, manage projects and stakeholder relationships. The role collaborates
closely with all stakeholders across the FDB to setup accurate master data for both material and production planning in the SAP ERP system.
The Upstream Engineer/Scientist 2 will provide tech transfer support and technical oversight for a large-scale cell culture in monoclonal antibody manufacturing.
The Engineer / Scientist 3, Downstream MSAT will provide tech transfer support and technical oversight for large scale purification activities for Monoclonal antibody production.
The Senior EHS Safety Specialist (internally known as Environmental Health & Safety Manager) will lead safety and environmental programs located in Richmond, VA and support multiple facilities, driving improved safety and environmental performance through thorough and accurate incident reviews, implementing programs to increase safety awareness and compliance, and ensuring safety meetings and training are meaningful and engaging. Provide oversight to ensure proper operation of environmental control system.
Territory Manager - N. Philadelphia - Remote
As a member of our sales team, you will sell portable ultrasound systems in a consultative, professional and high velocity sales environment. This includes creating primary market demand for FUJIFILM Sonosite products by networking, cold calling, and educating users in hospitals and the physician office market on the value of FUJIFILM Sonosite’s hand-carried compact ultrasound systems and tools.
This position requires previous capital medical equipment sales experience.
To best serve the territory, prefer candidates currently located in the North Philadelphia area
This role will lead and execute manufacturing processing steps, associated activities, and assist the supervisor as required. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
The Associate Manager of Instrumentation & Controls (I&C) ensures the efficiency and operational reliability of the site instruments through an effective calibration process. This role sets the direction and manages the development of the I&C team as the site transitions from construction to operations. Additionally, this role assists with establishing efficient programs designed fit for future operations by utilizing current Good Manufacturing Practice (cGMP) / Good Laboratory Practice (GLP) knowledge, work scheduling, instrument calibration, repair, and troubleshooting. This role also provides day-to-day oversight and development of the I&C team.
Summary: The Sample Management Analyst I, under general direction, will be responsible for performing routine and non-routine support of samples submitted to the Quality Control (QC) Laboratory for evaluation. This position works as part of the Sample Management team to manage the receipt, organization and inventory of samples from manufacturing, clients, other Fujifilm facilities and third parties. The Sample Management Analyst I arrange sample shipments for outsource testing and shipments to Clients or other facilities and controls dispensing of samples for QC testing.
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