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 is responsible for ensuring compliance with quality standards in the pharmaceutical industry. This role involves reviewing and approving documentation, performing quality audits, and acting as a liaison between various departments and external clients. The position requires a strong understanding of regulatory requirements and the ability to provide guidance and support to the QA team and other departments.

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 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.
• Notify Senior Management of potential quality or regulatory issues.
• Assist with technical oversight/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 the production of drug, biologics, or vaccine products.

Nice-to-haves

• Experience in a regulated industry such as pharmaceuticals or biotechnology.
• Familiarity with quality management systems and tools.