FUJIFILM Biotechnologies · 2 months ago
QA Specialist III, Quality Systems/Data Integrity (On-Site in College Station, TX)
United States
Full-time
Remote
Mid Level
3+ years expFUJIFILM Biotechnologies is seeking a proactive and driven QA Specialist III for Data Integrity to support their Data Integrity projects in Texas. The role involves managing the Data Integrity Program, performing assessments, and ensuring compliance with quality systems and regulations.
BiotechnologyHealth CareManufacturing
Hiring Manager
Lisa Cramer, MBA, MLS
Responsibilities
Work collaboratively with all levels of the FUJIFILM Biotechnologies, Texas 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 FUJIFILM Biotechnologies 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 FUJIFILM Biotechnologies, Texas 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 FUJIFILM Biotechnologies 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
Qualification
Required
Bachelor's degree with 3+ years of experience in Pharmaceutical, Biotechnology or other regulated Industry
Master's Degree with 1+ years experience in Pharmaceutical, Biotechnology or other regulated Industry
Involvement in Data Integrity projects during previous roles
Strong understanding of 21 CFR Part 11 and Annex 11 regulations, FDA, GMP, GAMP and ISPE
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
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
Company
FUJIFILM Biotechnologies
For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.
Founded in 2011Morrisville, North Carolina, USA
1001-5000 employees
H1B Sponsorship
FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Lars Petersen
President & Chief Executive Officer
Morten Munk
Director - Global Alliance Management
Recent News
Morningstar.com
2025-10-30
Company data provided by crunchbase