Senior QA Specialist — Deviation, CAPA & Audits

FUJIFILM Electronic Materials U.S.A., Inc.

College Station (TX)

On-site

USD 65,000 - 88,000

Full time

14 days+

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Job summary

FUJIFILM Biotechnologies Texas is seeking a Quality Assurance Specialist III for its Bryan, TX site. The role focuses on reviewing and approving Quality System Records and coordinating deviations, CAPAs, and customer complaints to ensure regulatory compliance.

The candidate must have a master’s or bachelor’s degree in a related field with 1–3 years QA experience in a regulated industry, and experience with cGMP manufacturing and audits will be valuable.

Qualifications

Requires a master’s or bachelor’s degree in a life sciences or engineering field and 1–3 years QA experience in regulated environments.
Experience with cGMP regulations in drug, biologics, or vaccine manufacturing preferred.
Experience presenting at audits/inspections and leading QA training content creation.

Responsibilities

Review and approve Quality System Records (Deviations/CAPAs/Complaints).
Coordinate remediation and closure of quality investigations.
Monitor daily metrics for deviations, CAPAs, and client complaints; ensure timely closures.
Assist with client due diligence, quality audits, and regulatory inspections.
Support cross‑functional teams (Facilities, Materials Management, QA, Validation).