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Quality Control - Stability Coordinator III
FUJIFILM Holdings America Corporation | |||||||
United States, Texas, College Station | |||||||
May 22, 2023 | |||||||
Quality Control - Stability Coordinator III Job Locations
US-TX-College Station
Overview Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)
The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki. 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, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee and compile the stability testing and data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA's and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software. External US Essential Functions:
Assists in preparing QC metrics on a monthly basis
Required Skills & Abilities:
Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
Minimum Qualifications:
Preferred Qualifications:
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500. #LI-SB2 |