QA Specialist III, Data Integrity

Position Overview

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.

 

Reports to                Senior Director, QA Compliance

Work Location         College Station, TX 

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

 

Job Description

Primary Responsibilities:

• Work collaboratively with all levels of the FDBT site to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
• Act as an ambassador for FDBT Quality Culture.
• Deputize fronting Data Integrity in customer and regulatory audits (as required).
• Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.
• Work as a change agent to compliantly improve existing or introduce new ways of working.
• Strong experience with GMP, manufacturing processes, quality and regulatory requirements.
• Ensure smooth operation of the FDBT Data Integrity program highlighting any issues in a timely manner.
• Provide guidance and advice to ensure Data Integrity remediation actions are successfully completed.
• Provide coaching and training for staff in Data Integrity Principles.
• Engage in global FDB projects and meetings to include being an active participant in work groups, and assessment of existing and new global systems.
• Schedule and perform assessments, gap confirmation and schedule stakeholder follow-up.
• Review pre-purchase of systems and analyze to ensure Data Integrity Compliance.
• Draft FMEAs and lead stakeholder meetings.
• Raise and manage change controls and CAPAs, and drive mitigation and remediation.
• All other duties as assigned.

 

Qualifications:

• Strong understanding of 21 CFR Part 11 and Annex 11 regulations, FDA, GMP, GAMP and ISPE.Develop staff to maximize contributions to the team and the company.
• Ability to multitask and easily prioritize work.
• Ability to work independently with little supervision.
• Proficient in Microsoft Excel, Word and PowerPoint.
• All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
• Bachelor’s degree with 3 years or more experience in Pharmaceutical, Biotechnology or other regulated Industry.
• Master’s Degree with 1 year or more experience in Pharmaceutical, Biotechnology or other regulated Industry.
• Involvement in Data Integrity projects during previous roles.
• Ability to collaborate effectively with stakeholders from across the business, at all levels.
• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Motivated cross functional worker.
• Ability to set and achieve personal performance goals.
• Provide input to departmental objectives.

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 es