Quality Assurance - Analyst I

Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: June 16, 2022

Job Description:

Overview Summary:The Quality Assurance (QA) Analyst I, under direct supervision, will be responsible for assisting with the review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements; External US Essential Functions:

• Assist with review of basic documentation to include, but not limited to:
  • Standard Operating Procedures
  • Corrective Action/Preventive Action Plans
  • Data Reports
  • Assist with review of internal Quality policies, procedures and reports
  • Assist with inspection of final product containers and review and/or approval of executed process records and data
  • Assist in Quality audits to include, but not limited to:
    • Audit of lab notebooks
    • Audit of equipment logbooks
    • 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
    • All other duties as needed.Required Skills & Abilities:
      • 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
        • All candidates will have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine productsWorking Conditions & 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.Qualifications:
            • 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.Preferred Qualifications:
              • ASQ Certification
              • Knowledge of GMP/GLP regulationsWe are 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.If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3528. -

Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Assurance - Analyst I, Professions , College Station, Texas