Quality Assurance Specialist III

17 hours ago

College Station, Texas, United States FUJIFILM Corporation Full time
Overview

FUJIFILM Corporation is seeking a highly skilled Quality Assurance Specialist III 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 pharmaceutical products.

Responsibilities
  • Review and approve basic and technical documentation, including Standard Operating Procedures, Batch Production Records, and Commissioning, Qualification, and Validation protocols and reports.
  • Draft and review internal Quality policies, procedures, and reports.
  • Perform inspection of final product containers and review and/or approval of executed process records and data.
  • Conduct Quality audits, including lab notebook audits, equipment logbook audits, and vendor, supplier, and contract laboratory audits.
  • Identify process and Quality System improvement opportunities and provide guidance on compliance with national and international standards and regulations.
  • Support Regulatory, client, and internal audits, and act as a QA liaison to internal departments and external client quality groups and vendor/contract laboratory quality groups.
Requirements
  • High school diploma or equivalent and 8+ years of experience in pharmaceutical or other regulated industries.
  • Associates degree and 5+ years of experience in pharmaceutical or other regulated industries.
  • Bachelor's degree and 3+ years of experience in pharmaceutical or other regulated industries.
  • Master's degree and 1+ year of experience in pharmaceutical or other regulated industries.
  • Certified Quality Auditor preferred.
  • Excellent written and oral communication skills, as well as organizational, analytical, data review, and report writing skills.
  • Ability to multitask, prioritize work, and work independently with minimal supervision.
  • Proficient in Microsoft Excel, Word, and PowerPoint.
  • Working knowledge of cGMP regulations for the production of drug, biologics, or vaccine products.
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 the essential functions.

  • Experience prolonged standing, some bending, stooping, and stretching.
  • 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.
About FUJIFILM Corporation

FUJIFILM Corporation is a global leader in the development and manufacturing of innovative products and services. We are committed to advancing tomorrow's medicine and empowering our employees to chase the impossible. We are a company of emboldened goal seekers who are driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

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