Quality Assurance Specialist I

6 days ago

Texas, United States FUJIFILM Diosynth Biotechnologies Full time

Job Summary:

Fujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Specialist I to join our team. The successful candidate will be responsible for ensuring the quality and compliance of our products and processes.

Key Responsibilities:

  • Quality Direction: Provide quality direction to the validation team during document review to ensure compliance with local and global quality standards, regulatory requirements, and partner commitments.
  • Collaboration: Work collaboratively with other site functions to instill a 'Quality Culture' by coaching in the application of GMP Principles, including the underlying rational of those principles.
  • Support: Support client due diligence and Quality audits as well as regulatory inspections.
  • Review and Approval: Reviews and approves master plans, pre/post approval of qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
  • Deviation and Discrepancy Management: Reviews and approves qualification and validation deviations and discrepancies, supports investigations and corrective actions.
  • Design Review: Participate in design reviews and have experience in reading P&ID's and various engineering drawings.
  • Coordination: Coordinate with Validation, Metrology, Facilities, Engineering, on a daily basis to ensure any GMP protocols, requirements etc. are completed in a timely manner.
  • Investigation and Reporting: Utilize investigative techniques to determine root causes of discrepancies and proper corrective and preventative actions. Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • Additional Responsibilities: Perform other duties and projects as assigned and required.

Qualifications:

  • Education: 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.
  • Knowledge and Skills: Knowledge of GMP/GLP regulations preferred. Degree in Biology, Chemistry or Engineering preferred. Role model for company core values of trust, delighting our customers, Gemba, and Genki.

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