Quality Assurance Specialist III
Job Location:
College Station, TX - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Job Title: Quality Assurance Specialist III
Employer: FUJIFILM Diosynth Biotechnologies Texas LLC
Position Description:
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 importantand we are looking for passionate mission-driven people like you who want to make a real difference in peoples 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 youre ready to help transform the future of medicine join FUJIFILM Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat 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 its a dynamic location that blends convenience with innovation.
NOTICE: Pursuant to 20 C.F.R. 656.10 you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application with information on available workers and information on wages and working conditions to the Certifying Officer at the U.S. Department of Labor as follows: Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW Room N-5311 Washington DC 20210 Basic Qualifications: Masters 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. Location: The position is located at FUJIFILM Diosynth Biotechnologies Texas LLC 8872 Health Science Center Pkwy Bryan TX 77807 Salary: $65000 - $88230 /year Position qualifies for employee referral program. For confidential consideration apply at Requisition ID # Fujifilm is committedto 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. 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 ( or ).
Fujifilm is globally headquartered in Tokyo with over 70000 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: Description
Must possess previous experience operating in a position where cGMP regulations govern the production of drug biologics or vaccine products.
Required Experience:
IC
