Quality Assurance Specialist

4 weeks ago


College Station, Texas, United States FUJIFILM Diosynth Biotechnologies Full time
Job Summary

We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at FUJIFILM Diosynth Biotechnologies. The successful candidate will be responsible for assisting with the review and approval of basic and technical documentation, drafting and reviewing internal Quality policies and procedures, and assisting with product-related activities.

Key Responsibilities:
  • Assist with the review of basic documentation, including Standard Operating Procedures, Corrective Action/Preventive Action Plans, and Data Reports.
  • Assist with the review of internal quality policies, procedures, and reports.
  • Assist with the inspection of final product containers and review and/or approval of executed process records and data.
  • Assist in Quality audits, including the audit of lab notebooks, audit of equipment logbooks, and review of vendor, supplier, contract laboratory audit questionnaires.
  • Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
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.
  • All candidates will have a working knowledge of cGMP regulations to produce drug, biologics, or vaccine products.
  • Role model for company core values of trust, delighting our customers, Gemba, and Genki.


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