Quality Assurance Specialist

11 hours ago

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

Overview

FUJIFILM Holdings America Corporation is seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.

Key Responsibilities:
  • Assist in the review and approval of basic and technical documentation, including Standard Operating Procedures, Corrective Action/Preventive Action Plans, and Data Reports.
  • Review and assist in the drafting of internal quality policies and procedures.
  • Assist with product-related activities, including inspection of final product containers and review of executed process records and data.
  • Participate in Quality audits, including audit of lab notebooks, audit of equipment logbooks, and review of vendor, supplier, contract laboratory audit questionnaires.
  • Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Requirements:
  • Bachelor's degree in a related science concentration with some experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR Associate's degree in a related science concentration with 2+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products; OR High School Diploma or GED with 4+ years of experience in Quality Assurance supporting pharmaceutical or biotechnology products required.
  • ASQ Certification preferred.
  • Knowledge of GMP/GLP regulations 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 adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly.
  • Ability to work independently and establish work priorities to meet targets and timelines.
  • Proficient in Microsoft Office.
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.

While performing the duties of this job, the employee is regularly required to:

  • Experience prolonged sitting, some bending, stooping, and stretching.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • Lifting up to 25 pounds on occasion.
  • Ability to wear restrictive gowning for extended periods of time during periods of prolonged standing.

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