QA Analyst II - All Shifts

Fujifilm - College Station, TX

Full-time - Mid Level

College Station, TX

Machinery Manufacturing

About the position

The Quality Assurance (QA) Analyst II at FDB is responsible for ensuring compliance with quality standards in the production of pharmaceutical and biotechnology products. This role involves reviewing and approving documentation, assisting in quality audits, and acting as a liaison between internal departments and external quality groups. The position is crucial for maintaining product quality and regulatory compliance, contributing to the development of vaccines, cures, and gene therapies.

Responsibilities

• Review basic and technical documentation including Standard Operating Procedures, Analytical Methods, and Batch Production Records.
• Draft and review internal Quality policies and procedures.
• Assist in and perform Quality audit functions, including audits of lab notebooks and equipment logbooks.
• Act as a QA liaison to internal departments and vendor/contract laboratory quality groups.
• Notify the Supervisor of potential quality or regulatory issues that may affect product quality or compliance.
• Perform other duties as needed.

Requirements

• Master's degree in a related science concentration with 1+ year of experience in cGMP supporting pharmaceutical or biotechnology products; OR Bachelor's degree with 2+ years of experience; OR Associate's degree with 4+ years of experience including 2+ years in cGMP.
• Excellent written and oral communication skills.
• Strong organizational, analytical, data review, and report writing skills.
• Ability to adapt to frequent changes in the work environment and manage time effectively.
• Proficient in Microsoft Excel, Word, and PowerPoint.
• Working knowledge of cGMP regulations for drug, biologics, or vaccine production.

Nice-to-haves

• ASQ Certification preferred.
• Degree in Biology or Chemistry preferred.

Benefits

• Equal opportunity employer
• Flexible working hours
• Supportive work environment