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Position Overview
Quality Assurance Specialist III for FUJIFILM Diosynth Biotechnologies Texas, LLC. Responsible for the review and approval of Quality System Records (e.g. Deviations/CAPAs/Complaints) and will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance. Assist with the tracking and coordination and remediation and closing of Deviations/CAPAs/Complaints. Responsible for daily metrics pertaining to pending deviations, CAPAs, customer & client complaints to ensure on time closures.
Perform deviation, CAPA, customer complaint quality oversight and write up of client complaints to ensure root cause analysis and write up of investigation are clear and concise. Conduct timely information gathering sessions with cross-functional departments to obtain the required information and data to complete the review and closure of investigations. Support client due diligence and Quality audits as well as regulatory inspections. Work with Quality management to implement and grow phase-appropriate quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.
Support client audit requests. Ensure self, and team, have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions. Provide cGMP assistance with cross-functional departments, such as Facilities, Materials Management, Quality Assurance and Validation. Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
The work we do at FUJIFILM Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.
From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.
If you’re ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki.
Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers
Requirements: Master’s degree in Biology, Chemistry, Engineering or related field and one (1) year of experience as a quality assurance specialist or related occupation in quality assurance; OR Bachelors degree in Biology, Chemistry, Engineering or related field and three (3) year of experience as a quality assurance specialist or related occupation in quality assurance.
Must possess one year of experience with Masters, or three years of experience with Bachelors with the following: Quality Assurance experience in Pharmaceutical or other regulated industry; Experience presenting under Audit and Inspection; Building and leading training content related to quality system records; Using a digital Quality Management System platform; and Technical writing.
Must possess previous experience operating in a position where cGMP regulations govern the production of drug, biologics or vaccine products.
Salary: $65,000 - $88,230 /year
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
Legal notes
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500).
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