A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FDBT. The Quality Assurance (QA) Specialist III for Data Integrity will be responsible for the day to day running of the FDBT Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks.  

Summary:  The Senior Training Specialist is responsible for design, development, and delivery of training for the FUJIFILM Biotechnologies Organization. They must be able to think creatively when working with Subject Matter Experts across the organization to translate complex ideas into effective training that pertains to trainee’s role and performance. Additionally, they must be proactive in identifying training needs of individuals and ensure they are met. An ability to prioritize and plan is essential to ensure training obligations and other duties are met.

Summary:   FUJIFILM Biotechnologies Texas (FDBT) is seeking a Senior eQMS Specialist to support the configuration, implementation, analysis, and maintenance of the electronic Quality Management Systems (eQMS). This role ensures system compliance with cGMP and regulatory requirements while optimizing eQMS functionality and efficiency. The ideal candidate will have strong technical expertise in eQMS systems and experience with quality system validation and compliance.

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

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 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 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. 

A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FDBT. The Quality Assurance (QA) Specialist II for Data Integrity will be responsible for the day to day running of the FDBT Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks.  

Summary:  The Quality Assurance (QA) Compliance Specialist III – Change Control, will be responsible for supporting performance of the Quality Systems group.  The Specialist will assist with the tracking and coordination and closure Change Control records.     Reports to