QA Analyst III - Day Shift

Fujifilm - College Station, TX

Full-time - Mid Level

College Station, TX

Machinery Manufacturing

About the position

The Quality Assurance (QA) Analyst III at FDB 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 internal departments and external clients. The position requires a strong understanding of regulatory requirements and the ability to identify areas for process improvement. The QA Analyst III plays a critical role in maintaining product quality and regulatory compliance, contributing to the development of vaccines, cures, and gene therapies.

Responsibilities

• Review and/or 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 that may affect product quality or compliance.
• Assist with technical oversight/training for the QA team.
• Assist with compliance-related functions.

Requirements

• High school diploma or equivalent with 8+ years' experience in Pharmaceutical or other regulated Industry.
• Associate's Degree with 5+ years' experience in Pharmaceutical or other regulated Industry.
• Bachelor's degree with 3+ years' experience in Pharmaceutical or other regulated Industry.
• Master's Degree with 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 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 beyond pharmaceuticals.
• Familiarity with quality management systems.

Benefits

• Competitive salary
• Health insurance
• 401k plan
• Paid time off
• Professional development opportunities