Quality Assurance Specialist

4 weeks ago

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

At FUJIFILM Diosynth Biotechnologies, we are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. The successful candidate will be responsible for assisting with the review and approval of basic and technical documentation, drafting and reviewing internal Quality policies and procedures, and assisting with product-related activities.

Key Responsibilities:

  • Assist with the review of basic documentation, including Standard Operating Procedures, Corrective Action/Preventive Action Plans, and Data Reports.
  • Assist with the review of internal quality policies, procedures, and reports.
  • Assist with the inspection of final product containers and review and/or approval of executed process records and data.
  • Assist in Quality audits, including the audit of lab notebooks, equipment logbooks, and 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. Attendance is mandatory.

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