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Summary: The QC Stability Coordinator III, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.
The Quality Control Coordinator III, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology,...
The Senior Financial Business Partner provides strategic financial support to the business. This position requires a blend of financial expertise, business acumen and the ability to influence and drive strategic initiatives. This role acts as a key advisor to the Program Management leadership, supporting all financial elements relating to revenue recognition accounting, contract review and approval and sales to program margin forecasting. This role is also responsible for ensuring financial goals are met and business strategies are effectively implemented. The role involves engaging with business partners to understand business processes, performance, highlighting risks and opportunities, and...
The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.
The Business Innovation Division of FUJIFILM North America Corporation is the largest graphic distributor in the US. We deliver world class, state of the art solutions for Ink Jet Printing, Digital Printing, Wide Format, Offset Plates, Packaging, and a full range of traditional Offset supplies. In addition, we are the industry leader in Color Standardization and G7 implementation.
The preferred location for this position is near a major airport.
As the Associate Director of Microbiology, you will play a pivotal role in overseeing all microbiological testing and ensuring the highest standards of quality, data integrity, and compliance at our manufacturing site. You will leverage your expertise to guide our efforts in maintaining a contamination-free environment, support our product pipeline, and ensure regulatory compliance.
Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking a Document Control Supervisor to lead and oversee document control processes within the Quality Assurance function. This role ensures compliance with regulatory requirements, Fujifilm's quality policies, and site standard operating procedures (SOPs). The Document Control Supervisor will provide leadership, oversight, and hands-on execution to maintain the integrity, accessibility, and organization of quality documentation, while leading a team of both contract and full-time document control specialists.
The Manufacturing Technician I works directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following:
The QA Specialist, LMS is responsible for collaborating alongside current team members with the creation of curriculum, serving as ComplianceWire administrator, assisting in the continual development of FUJIFILM Diosynth Biotechnologies' education program, co-developer of internal PQS SharePoint site, overall site training ambassador to help encourage, motivating and assisting in meeting deliverables and timelines and more. Works closely with other Fujifilm Diosynth Biotechnologies sites to gain alignment and efficiency.
An Imaging Service Engineer II is responsible for performing scheduled and unscheduled service work on systems within a service area as directed by the Area Service Manager.
The Computer System Validation (CSV) Engineer III, under general direction, will lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.
The Manager, QC Lab Support is responsible for leading the Lab Support team and the associated activities to ensure compliant and reliable testing for drug substance and drug product. This role applies broad knowledge and expertise in the areas of biopharmaceutical Quality Control for QC Chemistry, QC Bioassay, QC Microbiology, etc. and operational excellence. This Manager, QC Lab Support provides tactical and strategic direction to the QC Lab Support team and promotes the behaviors and principles that drive continuous improvement throughout the organization.
The Validation Engineer III, under general direction, will be responsible for drafting and executing validation protocols for Facilities, Utilities, Systems and Equipment (FUSE), as well as preparing validation final reports for the same.
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Solution Preparation Unit Operations. This individual will supervise a team of employees directly or indirectly in these production process units.
The Automation Engineer 3 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 leading the Automation scope for delivery of DeltaV logic for CIP & Clean Utilities process areas including Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection.
The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations. This individual will supervise a team of employees directly or indirectly in these production process units.
The Senior Automation Engineer 1 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 leading the Automation scope for delivery of DeltaV logic for CIP & Clean Utilities process areas including Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection.
The Senior Automation Engineer 1, MES provides 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 will lead projects and handle complex changes while coordinating with other internal and external groups
The Microbiology III will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Diosynth Biotechnologies Texas (FDBT) Quality Control Laboratory.
Company Overview:
About FUJIFILM Locally: FUJIFILM Imaging Colorants, Inc. is part of FUJIFILM’s Ink Solutions Group comprised of four companies based in the UK, USA, and India. Fujifilm Imaging Colorants, Inc. has a manufacturing site in New Castle, DE where aqueous dyes, RxD, and inks are made to support the Inkjet digital printing...