QA CAPA Lead - cGMP Compliance & Audit Readiness

FUJIFILM Holdings America Corporation

College Station (TX)

On-site

USD 65,000 - 88,230

Full time

14 days+

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Job summary

FUJIFILM Diosynth Biotechnologies Texas, LLC is seeking a Quality Assurance Specialist III in Bryan, TX. The role focuses on review and approval of Quality System Records, tracking and remediating Deviations/CAPAs/Complaints, and ensuring regulatory compliance.

The position requires advanced QA experience in regulated environments, experience with audits, training content development, and strong technical writing skills, supporting cGMP manufacturing from pre-clinical to commercial stages.

Qualifications

Master’s degree in Biology, Chemistry, Engineering or related field and 1 year QA exp; OR Bachelor’s degree and 3 years QA exp.
Experience in Pharmaceutical or regulated industry QA.
Experience presenting under Audit and Inspection.
Building and leading training content related to quality system records.
Using a digital Quality Management System platform.
Technical writing experience.

Responsibilities

Review and approve Quality System Records (Deviations/CAPAs/Complaints).
Coordinate remediation and closure of deviations/CAPAs/complaints.
Monitor daily metrics for pending quality items to ensure on-time closures.
Oversee deviations, CAPAs, and customer complaint investigations for root-cca and write-ups.
Gather information from cross-functional departments to close investigations.
Support client due diligence, quality audits, and regulatory inspections.