Senior QA Analyst - Night Shift

Fujifilm - College Station, TX

Full-time - Mid Level

College Station, TX

Machinery Manufacturing

About the position

The Senior Quality Assurance (QA) Analyst at FUJIFILM Diosynth Biotechnologies plays a crucial role in ensuring the quality and compliance of pharmaceutical products. This position involves reviewing and approving documentation, performing quality audits, and acting as a liaison between various departments and external clients. The analyst will also identify opportunities for process improvements and provide guidance to ensure adherence to national and international quality standards.

Responsibilities

• Review and approve basic and technical documentation with minimal supervisory oversight.
• Draft and review internal Quality policies, procedures, and reports.
• Perform inspection of final product containers and review executed process records and data.
• Conduct Quality audit functions, including audits of lab notebooks and equipment logbooks.
• Lead vendor, supplier, contract laboratory, and client audits.
• Identify process and Quality System improvement opportunities.
• Provide daily guidance for compliance with QA department standards and regulations.
• Support Regulatory, client, and internal audits.
• Act as QA liaison to internal departments and external client quality groups.
• Notify Senior Management of potential quality or regulatory issues.
• Assist with technical oversight and training for the QA team.
• Ensure priority task coverage and escalate issues as needed.

Requirements

• Master's Degree and 3+ years of Pharmaceutical or other regulated Industry experience.
• Bachelor's Degree and 5+ years of Pharmaceutical or other regulated Industry experience.
• Associate's degree and 7+ years of Pharmaceutical or other regulated Industry experience.
• 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 prioritize work effectively.
• Ability to work independently with little supervision.
• Proficient in Microsoft Excel, Word, and PowerPoint.
• Working knowledge of cGMP regulations for drug, biologics, or vaccine production.

Nice-to-haves

• Experience in a regulated industry outside of pharmaceuticals.
• Familiarity with quality management systems.

Benefits

• Health insurance coverage.
• 401k retirement savings plan.
• Paid holidays and vacation time.
• Professional development opportunities.