QA Analyst I - All Shifts

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 a vital role focused on ensuring compliance with quality standards in the pharmaceutical industry. The analyst will assist in reviewing and approving documentation, drafting internal quality policies, and supporting quality audits. This position is essential for maintaining product quality and regulatory compliance, contributing to the development of vaccines, cures, and gene therapies.

Responsibilities

• Assist with review of basic documentation including Standard Operating Procedures, Corrective Action/Preventive Action Plans, and Data Reports.
• Assist with review of internal quality policies, procedures, and reports.
• Assist with inspection of final product containers and review and/or approval of executed process records and data.
• Assist in Quality audits including audit of lab notebooks and equipment logbooks.
• Review vendor, supplier, and contract laboratory audit questionnaires.
• 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 pharmaceutical or other regulated industry; OR Associate's degree in a related science concentration with 2+ years of experience; OR High School Diploma or GED with 4+ years of experience in pharmaceutical or other regulated industry 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 and allocate, adjust and optimize time accordingly.
• Ability to work independently and establish work priorities to meet targets and timelines.
• Proficient in Microsoft Office.
• Working knowledge of cGMP regulations to produce drug, biologics, or vaccine products.

Nice-to-haves

• Experience in a regulated industry such as pharmaceuticals or biotechnology.
• Familiarity with quality assurance processes and documentation.

Benefits

• Equal opportunity employer with affirmative action policies.
• Support for employees with disabilities during the application process.