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 plays a crucial role in ensuring the quality and compliance of pharmaceutical and biotechnology products. This position involves reviewing and approving technical documentation, assisting in quality audits, and acting as a liaison between various departments and external quality groups. The QA Analyst II is responsible for identifying process improvements and ensuring adherence to cGMP regulations, contributing to the overall mission of creating innovative medical solutions.

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 auditing lab notebooks and equipment logbooks.
• Act as a QA liaison to internal departments and vendor/contract laboratory quality groups.
• Notify Supervisor of potential quality or regulatory issues affecting 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 in a related science concentration with 2+ years of experience in cGMP supporting pharmaceutical or biotechnology products; OR
• Associate's degree in a related science concentration with 4+ years of experience in a regulated industry, including 2+ years of experience in cGMP supporting pharmaceutical or biotechnology products; OR
• ASQ Certification preferred.
• Degree in Biology or Chemistry preferred.
• Excellent written and oral communication skills.
• Strong organizational, analytical, data review, and report writing skills.
• Ability to set personal performance goals and contribute to departmental objectives.
• Adaptability to frequent changes in the work environment and effective time management.
• Ability to work independently and prioritize tasks effectively.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Working knowledge of cGMP regulations for drug, biologics, or vaccine production.

Nice-to-haves

• ASQ Certification
• Experience in a regulated industry
• Knowledge of quality assurance processes

Benefits

• Health insurance
• 401k plan
• Paid time off
• Flexible scheduling
• Professional development opportunities