The Associate Director of Quality Control Compliance is a pivotal role within the Quality Control department, responsible for ensuring adherence to quality systems and regulatory standards. This position is dedicated to overseeing key QC processes, including the lifecycle management of QC SOPs, training curricula, change control, deviation management, and data integrity. This leader will drive compliance within the Quality Control function.

The Manufacturing Technician III will work directly with a range of technologies. Dependent upon assignment, the range of technologies exposed to will be:

The Field Service Technician – Level 2 will report to the Regional Service Manager and will be responsible for the service and maintenance of a single product line that the service team supports. This level technician will demonstrate a full working knowledge of a product line including theory of operation as well as the mechanics. This position will require travel throughout the United States. This position is remote, but should be located in the Maryland area

The Senior Engineer 1, EHS is responsible for leading the development and execution of Environmental, Health, Safety and Sustainability programs. This includes compliance with applicable regulations (Federal, State, Local), codes and standards. Serves as a subject matter expert (SME) and will collaborate with assigned functional operation areas to instill a world class culture of EHS. Additional responsibilities include support of EHS engagement programs (EHS observations, GEMBA), training, audits, inspections, investigations, and collaboration with EHS personnel across the organization.

The Manufacturing Technician II work directly with a range of technologies. 

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 QC Data Reviewer plays a vital role in Quality control group and 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.

The Quality Control Chemist II, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.  Following Tech-Transfer Activities, the candidate will be responsible for performing release and stability testing using the established analytical methods.  

Provides field technical support for key account and/or strategic customers on all aspects of established and new products.  Visits customer sites regularly to solve problems, build relationships, understand specific support requirements, and lead application development activities.  Provides and coordinates technical training for customer personnel.  Assists Sales, Business Development, and other staff in the practical application of company products to meet customer needs.  Provides support in disseminating technical information for specific applications.  Travel will average at least 50% through serving select, top tier customers within assigned territory /...

This position is intended to sell Ultrasound imaging systems, options, and service contracts to prospective and existing customers in their assigned territory.

Summary:  The Senior Project Manager is responsible for leading and executing strategic projects within the site, ensuring alignment with organizational goals and regulatory standards. This role involves managing multiple projects from inception to completion, optimizing project delivery, and fostering cross-functional collaboration to achieve business objectives.

The Lead National Support Specialist [NS3], provides an additional level of expertise and experience to the customer service national support specialists team. The Lead NS3 will assist in driving all aspects of customer support related issues, and problems, requiring escalation or high priority of each product including, but not limited to: storage, PACS, VNA, Mobility, 3D Systems, Syncomm and Clinical Information Systems for Radiology to ensure an optimal customer experience and timely resolution to high priority issues.

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. 

The Scientist 1, QC Microbiology (Drug Product & Raw Materials) supports a broad range of microbiological functions for both raw materials and drug product manufacturing support. This role manages multiple assignments of increasing complexity and responsibility within the Quality Control laboratory in support of these two areas. This role follows procedures and has mastery of a wide variety of microbiological methods specific to raw material and drug product manufacturing and supporting data management processes. The Scientist 1, QC Microbiology (DP and RM) effectively and efficiently manages complex or difficult tasks with expertise within the assigned disciplines. This role initially...

Summary:  Reporting to the Director of Engineering, the Sr. Process Engineer at Fujifilm Diosynth Biotechnology Texas (FDBT) oversees engineering activities, including equipment installation and product introduction support, infrastructure assessments, and troubleshooting for process equipment and site utilities. The role involves supporting a range of equipment such as bioreactors, incubators, filtrations systems, and others. The engineer collaborates with various teams—facilities, manufacturing, CAPEX, validation, QA/QC, and contractors—for project implementation and equipment maintenance. Key responsibilities include driving process improvements via Change...

This position is intended to process all outgoing shipments, incoming purchase orders, incoming goods, schedule and process parts for repair, maintain the order and the neatness of the warehouse, assist in the physical counts of inventory, respond to off-hours emergency parts requests, and perform all other duties as assigned.

The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.

The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

The QA Engineer, DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during project phase through to operational readiness. The QA Engineer, DSM is responsible for quality assurance oversight of day‐to‐day activities and resolution or mitigation of issues.

The QC Investigator/CAPA Specialist is responsible for supporting deviation investigations to ensure accurate, thorough, and on time completion. The incumbent applies systematic and analytical root cause analysis techniques inclusive of Human and Organizational Performance principles to each investigation.