Senior QA Lead — Biotech Compliance & Quality

FUJIFILM Biotechnologies; College Station (TX); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

FUJIFILM Biotechnologies Texas LLC in College Station, TX is seeking a Senior QA Analyst to review and approve critical documentation, participate in quality audits, and support QA compliance across drug, biologics or vaccine production.

Candidate must have advanced degree with relevant QA experience; familiarity with cGMP, CAPA, and batch record reviews is required. Strong cross-functional coordination and vendor/client QA collaboration are essential.

Formación

• Master’s or Bachelor’s degree as specified with required years of QA experience.
• Experience performing quality assurance activities in regulated environments.
• Knowledge of cGMP for drug/biologic/vaccine production.
• Experience with deviation investigations and CAPA.
• Experience reviewing production batch records and technical documents.

Responsabilidades

• Review and approve basic and technical documentation with minimal supervision.
• Lead QA audits and participate in vendor, supplier, and client audits.
• Provide guidance to manufacturing, QC, and other departments on QA requirements.
• Support regulatory, client, and internal audits and ensure compliance with standards.
• Act as QA liaison to internal teams and external client groups.

Conocimientos

QA auditing

Regulatory compliance

CAPA

Documentation review

Cross-functional collaboration

Educación

Master's degree in Project Management/Biology/Chemistry or related field

Bachelor's degree in Project Management/Biology/Chemistry or related field

Herramientas

DeltaV

SAP

Veeva

TrackWise

MasterControl

Descripción del empleo

FUJIFILM Biotechnologies Texas LLC in College Station, TX is seeking a Senior QA Analyst to review and approve critical documentation, participate in quality audits, and support QA compliance across drug, biologics or vaccine production.

Candidate must have advanced degree with relevant QA experience; familiarity with cGMP, CAPA, and batch record reviews is required. Strong cross-functional coordination and vendor/client QA collaboration are essential.