Quality Assurance Specialist

6 days ago

College Station Texas, United States Fujifilm Full time
Quality Assurance Analyst III

At Fujifilm, we are committed to advancing tomorrow's medicine and empowering our employees to chase the impossible. We are seeking a highly skilled Quality Assurance Analyst III to join our team in College Station, TX.

Job Summary

The Quality Assurance Analyst III will be responsible for reviewing and approving basic and technical documentation, drafting and reviewing internal Quality policies and procedures, performing product-related activities, and acting as a QA liaison internally and externally.

Key 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.
  • Perform Quality audit functions, including audit of lab notebooks, audit of equipment logbooks, and review of vendor, supplier, contract laboratory audit questionnaires.
  • Identify process and Quality System improvement opportunities and provide daily guidance for the compliance of the QA department to national and international standards and regulations.
  • Support Regulatory, client, and internal audits, and act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.
Requirements
  • High school or equivalent and 8+ years' experience in Pharmaceutical or other regulated Industry.
  • Associates Degree and 5+ years' experience in Pharmaceutical or other regulated Industry.
  • Bachelor's degree and 3+ years' experience in Pharmaceutical or other regulated Industry.
  • Master's Degree and 1+ years' experience in Pharmaceutical or other regulated Industry.
  • Certified Quality Auditor preferred.
  • Degree in Biology or Chemistry preferred.
What We Offer

Fujifilm is an equal opportunity and affirmative action employer. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

We are committed to creating a diverse and inclusive work environment that values and respects the contributions of all employees. If you are a motivated and detail-oriented individual who is passionate about quality and compliance, we encourage you to apply for this exciting opportunity.

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