Senior Quality Assurance Analyst

1 day ago

College Station, Texas, United States FUJIFILM Holdings America Corporation Full time
Job Title: Senior Quality Assurance Analyst

Overview

The Senior Quality Assurance Analyst will play a critical role in ensuring the quality and compliance of our products. This position will be responsible for reviewing and approving documentation, drafting and reviewing quality policies and procedures, and performing quality audit functions.

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.
  • Provide daily guidance for the compliance of the QA department to national and international standards and regulations.
  • Support Regulatory, client, and internal audits.
  • Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.

Requirements:

  • Master's Degree and 3+ years of Pharmaceutical or other regulated Industry experience.
  • Bachelor's Degree and 5+ years of Pharmaceutical or other regulated Industry experience.
  • Associate's degree and 7+ years of Pharmaceutical or other regulated Industry experience.
  • Certified Quality Auditor preferred.
  • Degree in Biology or Chemistry preferred.
  • 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 your work.
  • Ability to work independently with little supervision.
  • Proficient in Microsoft Excel, Word, and PowerPoint.

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.

About FUJIFILM Holdings America Corporation:

FUJIFILM Holdings America Corporation is a leading provider of innovative solutions for the healthcare, graphic systems, and electronic materials industries. We are committed to advancing tomorrow's medicine and impassioning employees to chase the impossible.

Equal Opportunity Employer:

FUJIFILM Holdings America Corporation is 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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