QA Analyst I, Analytical

Fujifilm - College Station, TX

Full-time - Entry Level

College Station, TX

Machinery Manufacturing

About the position

The Quality Assurance (QA) Analyst I position at FUJIFILM Diosynth Biotechnologies is an entry-level role focused on supporting quality assurance processes in the pharmaceutical and biotechnology sectors. The analyst will assist in reviewing and approving documentation, conducting quality audits, and identifying improvements in quality systems. This role is essential in ensuring compliance with regulatory standards and maintaining product quality.

Responsibilities

• Assist with review of basic documentation including Standard Operating Procedures and Data Reports.
• Assist with review of internal quality policies, procedures, and reports.
• Assist with inspection of final product containers and review of executed process records and data.
• Assist in Quality audits including audit of lab notebooks and equipment logbooks.
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Perform all other duties as needed.

Requirements

• Bachelor's degree in a related science concentration with some experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
• Associate's degree in a related science concentration with 2+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR
• High School Diploma or GED with 4+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products required.
• ASQ Certification preferred.
• Knowledge of GMP/GLP regulations preferred.
• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Ability to set personal performance goals and provide input to departmental objectives.
• Ability to adapt to frequent and rapid changes in the work environment.
• Ability to work independently and establish work priorities to meet targets and timelines.
• Proficient in Microsoft Office.

Nice-to-haves

• Working knowledge of cGMP regulations to produce drug, biologics, or vaccine products.