QA Analyst (Quality Assurance Analyst)

$25,000 - $47,000/Yr

Fujifilm - College Station, TX

Full-time - Entry Level

Onsite - College Station, TX

Machinery Manufacturing

About the position

The Quality Assurance (QA) Analyst I position at FUJIFILM Diosynth Biotechnologies involves supporting the review and approval of documentation related to quality assurance in the pharmaceutical and biotechnology sectors. The role is essential in ensuring compliance with quality standards and regulations, contributing to the development of vaccines and therapies. The position is based in College Station, TX, and requires a commitment to maintaining high-quality standards in a dynamic work environment.

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 and/or approval 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 and allocate, adjust and optimize time accordingly.
• 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.