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Quality Assurance Specialist

2 months ago

College Station Texas, United States Fujifilm Full time
About the Role

Fujifilm is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities
  • Provide quality direction to the validation team during document review to ensure compliance with local and global quality standards, regulatory requirements, and partner commitments.
  • 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 client due diligence and Quality audits as well as regulatory inspections.
  • 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.
  • Reviews and approves qualification and validation deviations and discrepancies, supports investigations and corrective actions.
  • Participate in design reviews and have experience in reading P&ID's and various engineering drawings.
  • Coordinate with Validation, Metrology, Facilities, Engineering, on a daily basis to ensure any GMP protocols, requirements etc. are completed in a timely manner.
  • 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.
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.
  • Knowledge of GMP/GLP regulations preferred.
  • Degree in Biology, Chemistry or Engineering preferred.
Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • Experience prolonged standing, 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.
  • Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
  • Lifting up to 25 pounds on occasion.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.