The QA Specialist III, QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, computer automation validation protocols and final reports and discrepancies for Quality Assurance. The QA Compliance Specialist III, QA Validation, will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.  

The Quality Control Analytical technologies (QCAT) group is seeking a dynamic Senior Scientist to manage the team-based execution of assay protocol driven activities for client programs.  The QCAT group is a technologically diverse group that primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. This high performing group is the interface between the development and quality groups and is responsible for ensuring long term success of the methods entering into QC.

The Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. 

Summary:  The Quality Assurance - Compliance Specialist III - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

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, Arizona facility for a Manufacturing Technician in our Solvents group!  

The Planner 2, Maintenance ensures the reliability and efficiency of the equipment and systems at the facility. This role uses knowledge of maintenance processes and regulatory requirements to plan, schedule, and coordinate maintenance activities to optimize operational productivity and minimize downtime. Additionally, this role seeks opportunities for continuous improvement and collaborates cross-functionally to ensure successful completion of maintenance activities.

The Scientist 1, Global QC Raw Materials (Microbiology) liaises with various external collaborators, contract laboratory organizations, QC testing teams and QA groups to ensure training needs, internal procedures, specifications, and protocols are met. This role ensures compliance with the pharmacopoeias and ICH guidelines. This role generates protocols and reports to support tech transfer activities and performs change control assessment activities for tech transfers to include, implementation of new raw materials, new test laboratories, specifications updates e.g. new methods and new vendors.

The Sr. Specialist 2, Global QC Raw Materials GMP Support is responsible for supporting, leading, and participating in activities within the Quality Control Raw Materials department as it relates to Investigations, Deviations, CAPAs and Change Controls. This role supports continuous improvements initiatives, customer contacts, and CLO communications to ensure Global QC Raw Materials (RM) capability of onboarding new materials, updating existing materials, implementing methods and ensuring campaign readiness as applicable.

The Sr. Specialist 2, Global QC Raw Materials (Documentation) is responsible for, but not limited to, implementing new raw materials, including specification authoring, requesting LIMS builds, and assessing changes. This role participates in planning and tracking QC readiness for clinical and commercial manufacturing, and ensures all documentation is in accordance with Good Manufacturing Practices (GMP) and that all reported results are accurate. The Sr. Specialist 2, Global QC Raw Materials onboards new materials in line with Fujifilm Diosynth Biotechnologies (FDB) and customer expectations. This role authors events, deviations, and CAPAs related to new materials, specifications, and other tech transfer activities.

The Scientist 1, Global QC Analytical Development Raw Materials is responsible for coordinating the transfer of analytical methods for raw materials into the FUJIFILM Biotechnologies Diosynth Quality Control Laboratory and external contract laboratory organizations (CLOs). This role liaises with customers, CLOs, QC testing teams, and QA groups to plan and track QC raw materials readiness for clinical and commercial manufacturing, which includes ensuring training needs, internal procedures, specifications, and protocols are met. This role ensures compliance with all GMP (Good Manufacturing Practices) regulatory guidelines. 

Represents Service and Technical Support for a variety of cross-functional initiatives including NPIs, reliability improvements, and product return investigations. Serviceability expert for the Sonosite product line, lending knowledge and expertise throughout the company. Provides product training to service personnel, including external biomeds. Responsible for additional duties and projects, as assigned by manager, which require a high-level understanding of products and/or processes.

We are hiring a R&D Scientist Intern- Manufacturing Science and Technology. The R&D Scientist Intern will provide R&D support of projects in product and process development by conducting laboratory research under the guidance of a supervisor.

As a DevOps Developer III in the Software Process & Quality team of our Software Engineering department, you will create, improve, and maintain our build automation tools and infrastructure, instrumentation hooks, and other related tools needed to ensure software functionality and quality of our complex medical ultrasound device products. These works will be consumed by you, your DevOps and Software Development peers, and your Software Tester counterparts to deliver build and test results and reporting that fulfills our software test plans, verification procedures, and the overall software and...

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 Pueblo, CO facility for a Lab Technician!   With state-of-the-art manufacturing facilities in the U.S., Europe,...

Summary: Laboratory Engineering Technical Support I is an entry-level position in the Laboratory Engineering department of FDBT.  The primary purpose of this position is to provide day-to-day technical support for the analytical pcs and equipment within Manufacturing, Quality Control, Analytical and Process Development organizations.  In addition, this position is a major contributor to supporting new technology and equipment life cycle monitoring.  Under...

The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.  

We have an exciting opportunity at our Mesa, Arizona facility for a Manufacturing Technician in our CMP slurries group!  The Manufacturing Technician - CMP supports receiving and cleaning containers, monitoring distillations, and packaging containers.

Territory Manager - Houston - 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...

Summary:  The Manufacturing Process Engineer I is an integral part of the Manufacturing Technical Operations department located in College Station, Texas.  This position will report directly to the Manager of Technical Operations, Manufacturing.

The Sr. QC Data Reviewer is responsible for ensuring compliance with Fujifilm’s Quality systems, policies, and procedures in accordance with U.S. and international regulatory agencies, ICH, general cGMP, and international guidance. This role involves leading the data review process to ensure accuracy, thoroughness, and timely completion in collaboration with cross-functional departments. The incumbent must possess a strong understanding of systematic reviews and data integrity, with skills and experience in cGMP data review requiring multi-departmental collaboration.