Quality Assurance Specialist II, Validation

20 hours ago


College Station Texas, United States Fujifilm Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist II, Validation to join our team at Fujifilm. This role will be responsible for ensuring the quality and compliance of our pharmaceutical products.

Key Responsibilities
  • Review and approve basic and technical documentation, including Standard Operating Procedures, Analytical Methods, and Batch Production Records.
  • 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 supervisor of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Requirements
  • Master's degree in a related science concentration with 1+ year of experience in cGMP supporting pharmaceutical or biotechnology products.
  • 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.
Preferred Qualifications
  • ASQ Certification.
  • Degree in Biology or Chemistry.
  • Proficient in Microsoft Excel, Word, and PowerPoint.
Physical Requirements
  • Prolonged sitting, some bending, stooping, and stretching.
  • Ability to sit for long periods to work on a computer.
  • Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.


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