Senior QA Specialist-eQMS

Overview

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. 

 

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.

 

Summary: This is an experienced role with in-depth and specialized knowledge of cGMP electronic systems.  This position can largely function with minimal or no supervisory oversight for routine duties.  Additionally, the Senior Quality Assurance Specialist, eQMS will implement, upgrade and maintain comprehensive electronic cGMP systems that are compliant with regulated requirements.  This role provides technical knowledge to the team and may act as a Quality representative in certain situations when necessary.   

External US

 

Essential Functions: 

• System Administration 

• System administration tasks including personnel changes and configuration changes. 

• Query support, mailbox management, process development 

• Assist in the implementation and maintenance of programs and processes in relation to electronic systems management. 

• Document Management 

• Function as SME for document processing protocols, regulations and best practices. 

• Coordination of Training 

• Identifies and develops necessary internal training as appropriate. 

• Supporting with the delivery of training for cGMP Electronic Systems. 

• Creation and maintenance of training requirements and curriculums for each system role in accordance with job functions. 

• Processing of System Reports 

• Running training reports to monitor compliance and for client/audit requests. 

• Building reports & dashboards on request. 

• Running reports necessary to maintain compliance with cGMP electronic systems in accordance with local SOPs. 

• General 

• Having a solid working knowledge of, and complying with, the Standard Operating Procedures of FujiFILM Diosynth Biotechnologies Texas (FDBT). 

• Working in a professional manner at all times with clients, customers, team members and management. 

• Complying with the Company’s Health and Safety Policies. 

• Ensuring that any confidential information or personal data related to FDBT and its clients is managed in accordance with Data Privacy regulations as described in FDBT SOPs. 

• Perform other duties as assigned. 

 

Required Skills & Abilities: 

• Perform as a SME for Quality Assurance eQMS. 

• Strong attention to detail. 

• Ability to multitask and prioritize work assignments with little supervision. 

• Demonstrated ability to work collaboratively in resolving inquiries and responding to problems and/or complaints from employees, vendors, customers, etc. 

• Demonstrated Leadership Abilities. 

• Resilient through operational and organizational change. 

• Exceptional planning and organizational skills and the ability to multi-task and meet deadlines are required. 

• Requires the ability to communicate effectively using speech, vision, hearing and written words. 

• Must be able to walk or move or drive between locations. 

• Interacts with all departmental staff, including giving training and / or presentations to small and large groups. 

• Adhere to the standards of quality ruled by current cGMP and the company Quality Policies and site SOPs. 

• Ability to accurately complete required documentation. 

• Knowledge of MS Office (Word, Excel, Outlook).
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• Preferred Experience, Behavioral Competencies, Skills & Ab