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 plays a crucial role in ensuring compliance with quality standards in the pharmaceutical industry. This position involves reviewing and approving documentation, performing quality audits, and acting as a liaison between internal departments and external clients. The QA Analyst III is responsible for identifying process improvements and ensuring adherence to national and international regulations, contributing to the overall mission of creating safe and effective biopharmaceutical products.

Responsibilities

• Review and approve basic and technical documentation including Standard Operating Procedures and Batch Production Records.
• Draft and review internal Quality policies and procedures.
• Perform inspections of final product containers and review executed process records.
• Conduct Quality audit functions including audits of lab notebooks and equipment logbooks.
• Lead vendor, supplier, and client audits.
• Identify opportunities for process and Quality System improvements.
• Provide guidance for compliance with QA department standards and regulations.
• Support Regulatory, client, and internal audits.
• Act as a QA liaison to internal departments and external Quality Groups.
• Notify Senior Management of potential quality or regulatory issues.
• Assist with technical oversight and training for the QA team.

Requirements

• High school diploma or equivalent with 8+ years of experience in Pharmaceutical or regulated industry.
• Associate's Degree with 5+ years of experience in Pharmaceutical or regulated industry.
• Bachelor's degree with 3+ years of experience in Pharmaceutical or regulated industry.
• Master's Degree with 1+ years of experience in Pharmaceutical or regulated industry.
• Certified Quality Auditor preferred.
• Degree in Biology or Chemistry preferred.
• Excellent written and oral communication skills.
• Strong organizational, analytical, data review, and report writing skills.
• Ability to set personal performance goals and prioritize work effectively.
• Ability to work independently with minimal 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 leadership role within Quality Assurance.
• Familiarity with regulatory compliance and audit processes.

Benefits

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