Quality Assurance Specialist II

7 days ago

College Station, Texas, United States FUJIFILM Corporation Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist II to join our team at FUJIFILM Corporation. As a key member of our supplier quality program, you will be responsible for ensuring the quality and compliance of our suppliers.

Key Responsibilities
  • Conduct supplier audits and assessments to ensure compliance with regulatory requirements.
  • Develop and maintain approved supplier lists.
  • Process and track supplier complaints.
  • Develop and issue weekly and monthly metric reporting on supplier performance.
  • Provide audit support and participate in Material Review Board (MRB) reviews.
Requirements
  • Master's degree in a science-related field with 1 year of cGMP experience supporting pharmaceutical or biotechnology products.
  • Excellent written and oral communication skills.
  • Ability to multitask and prioritize work.
  • Proficient in Microsoft Excel, Word, and PowerPoint.
  • Working knowledge of cGMP regulations for the production of drug, biologics, or vaccine products.
Preferred Qualifications
  • Degree in Biology, Chemistry, or Engineering.
  • Six Sigma Green/Black Belt cGMP experience.
  • ASQ Quality Auditor Certification.
Working Conditions

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 the essential functions.

The employee is regularly required to 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, 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. Must be willing to work flexible hours. Ability to work weekends and off-shift hours, as needed to support manufacturing activities. Must be willing to travel occasionally, as needed. Attendance is mandatory.

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