Fujifilm - College Station, TX
posted 2 months ago
The Quality Assurance (QA) Compliance Analyst II, Supplier Quality at FUJIFILM Diosynth Biotechnologies plays a crucial role in supporting the supplier quality program. This position is responsible for ensuring that all suppliers of raw materials, consumables, and GMP services are qualified before their use within the facility. The QA Analyst will act as a representative to external suppliers, providing essential support to the organization in conducting internal audits and hosting audits or inspections. This role requires interfacing and coordinating with sister sites on supplier quality systems, harmonization, and joint qualification efforts. Additionally, the QA Analyst will maintain an approved supplier list, process and track complaints to suppliers, and develop and issue weekly and monthly metric reports on supplier performance. The position also involves providing audit support as needed and participating in Material Review Board (MRB) reviews of nonconforming products, recommending appropriate dispositions and corrective actions. In terms of leadership, the QA Analyst will work collaboratively with site management to instill a ‘Quality Culture’ by coaching staff in applying Good Manufacturing Practices (GMP) principles, including the underlying rationale of those principles. The role also supports new business growth by assisting with client due diligence, quality audits, and regulatory inspections. The QA Analyst will work with quality management to implement and grow phase-appropriate quality systems that enable cGMP manufacturing of products from pre-clinical to commercial stages. This includes handling supplier complaints, managing change notifications, and approving specifications for quality assurance. The QA Analyst will serve as a Subject Matter Expert for various Supplier Quality Assurance (SQA) functions and will perform all other duties as assigned.