QA Analyst III - All Shifts

Position Overview

The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.

 

Reports to                Director, Quality Assurance/Senior Manager, Quality Assurance

Work Location         College Station, TX (On-site at NCTM building)

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. 

From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you’re ready to help transform the future of medicine, join FUJIFILM Diosynth Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki. 

Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Primary Responsibilities:

• Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to:
  • Standard Operating Procedures
  • Batch Production Records (completed and approval)
  • Commissioning, qualification and validation protocols and reports
  • Deviation Reports
  • Corrective Action/Preventive Action Plans
  • Technical data review and approval
  • QC data review and approval
  • Drug Substance/Product Reports
  • Trending QA data
• 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 to include, but not limited to:
  • Audit of lab notebooks
  • Audit of equipment logbooks
  • Review of vendor, supplier, contract laboratory audit questionnaires
  • 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.
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Assist with technical oversight/training for the QA team.
• Assist with compliance related functions.
• All other duties as assigned.

Qualifications:

• 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.
• Bachelor’s degree and 3+ years’ experience in Pharmaceutical or other regulated Industry.
• Master’s 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.
• All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.