Quality Assurance Specialist

2 days ago

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

Fujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance Analyst III to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our products.

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.
  • Lead vendor, supplier, contract laboratory and client audits.
  • 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:
  • 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.
  • Bachelors degree and 3+ years experience in Pharmaceutical or other regulated Industry.
  • Masters Degree and 1+ years experience in Pharmaceutical or other regulated Industry.
  • 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.

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