Quality Assurance Manager

6 days ago

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

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at FUJIFILM Corporation. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of quality in our products and processes.

Key Responsibilities
  • Document Review and Approval: Review and approve basic and technical documentation, including Standard Operating Procedures, Batch Production Records, and Commissioning, qualification and validation protocols and reports.
  • Policy and Procedure Development: Draft and review internal Quality policies, procedures, and reports to ensure compliance with regulatory requirements.
  • Quality Audit and Inspection: Perform inspection of final product containers and review and/or approval of executed process records and data.
  • Process Improvement: Identify process and Quality System improvement opportunities and implement changes to enhance quality and efficiency.
  • Regulatory Compliance: Provide daily guidance for the compliance of the QA department to national and international standards and regulations.
  • Regulatory Support: Support Regulatory, client, and internal audits to ensure compliance with regulatory requirements.
  • Communication and Collaboration: Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.
Requirements
  • Education: Master's Degree and 3+ years of Pharmaceutical or other regulated Industry experience, or Bachelor's Degree and 5+ years of Pharmaceutical or other regulated Industry experience, or Associate's degree and 7+ years of Pharmaceutical or other regulated Industry experience.
  • Certifications: Certified Quality Auditor preferred.
  • Skills: Excellent written and oral communication skills, excellent organizational, analytical, data review and report writing skills, ability to set personal performance goals and provide input to departmental objectives, ability to multitask and easily prioritize work, ability to work independently with little supervision, proficient in Microsoft Excel, Word, and PowerPoint.
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.

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