The QC Instrumentation Specialist will work independently to perform routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role will ensure compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role will ensure the performance of routine maintenance, completing periodic reviews of QC analytical instrumentation to confirm compliance and correct deviations and excursions. The role will also support stakeholders with issues and guidance related to QC analytical instruments. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success. This role is included in routine on-call and weekend support, as needed.

The Supply Chain Specialist 3, Compliance is responsible for actions, processes, and audit readiness. This role supports all Supply Chain operations, procedures, systems, processes, and GXP related matters in accordance with the GXP requirements. The SC Specialist 3, Compliance initiates and investigates internal and external exceptions impacting Supply Chain. This role leads the implementation of comprehensive corrective and preventative actions (CAPA) to drive improvements, coordinating vendor change notifications, raw material enrollment and supplier complaints. This role coordinates and is responsible for leading internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and customer requirements. The SC Specialist, Compliance will be coordinating change management record (CMR) for new raw material enrollment, supplier complaints and vendor change notifications.

The Manufacturing Supervisor may be assigned to work directly with Downstream operations. This individual will supervise a team of employees directly or indirectly in these production process units.

Position Summary:   This Manufacturing Engineering Internship opportunity is with Fujifilm Dimatix, Inc. located in Lebanon, NH.  The Manufacturing Engineer Intern will work under the guidance of Manufacturing Engineers to support the production of precision inkjet printheads.  Collaborate with engineers and technicians in a manufacturing environment that includes clean room and assembly floor areas.  Apply knowledge of engineering principles and problem solving to develop safety, quality, process, tooling and equipment improvements.  Document experiments and procedures with the opportunity to communicate to all levels of the organization. 

The Supervisor Quality Assurance Compliance – External Audit will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. The teams are broken up into two core functional groups: One will be overseeing the successful delivery of internal audits and the other one will be overseeing the successful delivery of external audits. You will be assigned to supervise one group or the other but may be asked to provide support to the whole Audit & Inspection group on occasion.

The Zone Pulmonary Sales Specialist is a key member of the Fujifilm Endoscopy sales team that is responsible for driving awareness, market share, and revenue growth across Fujifilm's Pulmonary product line. This includes flexible scopes, Endobronchial Ultrasound (EBUS), and all other pulmonary franchise offerings. The role is accountable for business development, strategic partnerships with Key Opinion Leaders (KOLs), and collaboration with the existing Fujifilm Endoscopy sales and clinical specialist teams to ensure successful demonstrations and customer satisfaction. Reporting directly to the Regional Sales Leader, the Zone Pulmonary Sales Specialist plays a pivotal role in expanding Fujifilm's presence in the pulmonary space.

The Technical Project Leader (TPL) provides technical and scientific leadership to external (client) and internal projects and is accountable for the delivery of the challenging technical elements of the program. The TPL guides customer projects through the initial kick-off and technical transfer stages, including process development and scale up, manufacturing readiness, and clinical GMP manufacturing.

The TPL directs the work of multi-disciplinary teams and ensures that project milestones are met on time and to budget, thus ensuring that program margins are achieved. The TPL also serves as the primary technical point of contact for the customer on a program, guides and informs them through the Project stages – from Tech Transfer through to GMP manufacture and disposition.

The Senior Technical Support Engineer, MI – I (Tier 1) provides highly visible remote technical support across our product lines for HCUS customers. This role focuses on more complex issue and is the second level support across our Synapse products. This engineer is expected be able to resolve most of the cases that are presented to them and responsible for documenting more in-depth evaluations of issues that they are unable to resolve. This engineer must be comfortable with making decisions while working on these more complex issues. This role requires a firm grasp of time management and organizational skills.

To meet the needs of our customers, working outside normal business hours and on some weekends/holidays is required. In addition to working OT to handle workload and meet required metrics/expectations.

The Quality Assurance (QA) Operations Supervisor, will be responsible for the overall performance of the QA group.  The supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.  

Reports to                Senior Manager, Quality Assurance

Work Location         College Station, TX 

The Technical Leader for Quality Control will be responsible for overseeing and guiding the technical work performed by a team of analysts in the biopharmaceutical sector. This role will focus on analytical release and stability testing of monoclonal antibodies (mAbs), gene therapy products, for both drug substances and drug products. The ideal candidate will possess a deep technical background, strong leadership skills, and a passion for fostering innovation and excellence within the QC team.

The Raw Materials Quality Control Chemist Lead, with limited supervision, will be responsible for mentoring the team on technical aspects of performing in-process, release and stability testing using the established analytical methods. Following Tech-Transfer Activities, the Lead will be responsible for performing in-process, release and stability testing using the established analytical methods.

The Raw Materials QC Manager is accountable for GMP compliant laboratory operations according to GMP guidelines. This role is responsible for direct management and supervision of the QC Raw Materials teams performing raw material testing according to USP/EP/JP guideline and releasing raw materials for use in the drug substance and drug product manufacturing process. The Manager, QC Raw Materials is responsible for managing raw material specifications, handling changes from customers on customer owned materials as well as handling and implementing new raw materials and consumables as part of tech transfer activities. In addition, the QC Raw Materials team is responsible for testing, disposition, and release of raw materials and Trackwise support or investigation of deviations including Out of Specification (OOS) results. Provide managerial support for troubleshooting of complex investigations and optimizing laboratory systems. Ensure that the laboratory is maintained in a state of GMP compliance. All documentation is in accordance with GMP and all reported results are accurate. The Manager, QC Raw Materials is the technical subject matter expert (SME) and participates in assessing the testing of raw materials and excipients, represents the QC Raw Materials team during regulatory and customer audits. The Manager models leadership competencies and aids in the development of QC team members.

The Quality Control Manager - Microbiology under general direction, will be required to plan, organize, direct, and evaluate the routine activities of the Quality Control staff and laboratory functions to ensure the safety and reliability of products produced in compliance with The Company Quality and various regulatory requirements. Candidates for this position must have experience in Microbiology (Product Testing, Environmental Monitoring and Utility Monitoring) in a regulated commercial pharmaceutical setting.  Strong candidates will have a working knowledge of additional QC functions in a regulated pharmaceutical setting.

Other responsibilities may include but are not limited to staff hiring, supervision, coaching, discipline and performing annual review assessments. Duties include reviewing data and problem solving in support of microbiological analysis.  Additional responsibilities may include supervision of specified chemical or biological testing.

The Quality Control Manager (Microbiology) candidate will also be involved in method verifications, and routine testing for incoming, in-process, release and stability testing on finished product, critical reagents, and raw materials, as needed. 

In the absence of Director and Associate Directors candidate will provide guidance to other groups within the QC organization.

The Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FDBT.  Responsibilities will include one or more PQS sub-system: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation.  Lead the assigned team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.  Ensure the site PQS sub-system is aligned with the harmonized global FDB PQS, organizational goals and objectives, and areas of continuous improvement.

This position is intended to provide mechanical and technical installation and repair for new/existing super-conductive MRI systems at customer sites.

The Quality Control Raw Materials Chemist III, 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 in-process, release and stability testing using the established analytical methods.

Job Title: Quality Control Raw Materials Chemist III

Reports to: Quality Control Chemistry Manager

The Quality Control Raw Materials Chemist I, under general direction, will be responsible for performing routine and non-routine quantitative and qualitative analysis of samples submitted to the Quality Control (QC) Laboratory.

Under general direction, the logistics project coordinator is responsible for the planning, scheduling, and coordination of all logistics activities following cGMP (current Good Manufacturing Practices) in support of manufacturing timelines and project deliverables.

The Senior Production Costing Analyst is responsible for enabling our site to deliver on financial and strategic objectives through forecasting, analysis, and reporting that guide business decisions. This role is integral in managing financial performance and implementing finance strategies to achieve business performance in a cross-functional team environment. The Senior Production Costing Analyst supports the business and drives finance initiatives and decisions. This role is a high performer who exudes a contagious level of positive energy, possesses a high sense of ownership, and has a strong ability to communicate and build rapport with non-financially minded peers.

We have an opportunity for a dedicated team player to be a part of a fast-paced, busy manufacturing environment! Fujifilm, Sonosite, Inc is seeking Manufacturing Associates to join our team. This role has full benefits, a 401K plan, paid time off, plus more perks that come with being a full time Fujifilm Sonosite employee! As a successful candidate you will exhibit manual dexterity, reliability, basic math and computer skills and an aptitude for learning things quickly. 

This position is responsible for performing a variety of tasks associated with manufacturing diagnostic ultrasound transducers.  Specific tasks may include some of the following: