QA Deviation Investigator & CAPA Lead

Lonza Biologics, Inc.; Tampa (FL); On-site; Confidential; Full time

Job summary

Lonza Tampa is seeking a QA Deviation Specialist to identify, document, investigate, and resolve deviations and unplanned events in line with cGMPs and SOPs. The role requires collaboration with manufacturing, QA, maintenance, engineering, and supply chain to drive root-cause analyses and CAPA effectiveness.

You will author and review investigations, ensure timely closures, and support regulatory inspections and GDP-compliant documentation, contributing to product quality and patient safety.

Qualifications

• Bachelor’s degree in science; chemistry preferred.
• 3+ years in quality assurance, deviation management, or related role.
• Knowledge of FDA, EMA, ISO regulatory requirements.
• Strong analytical and problem-solving abilities; excellent communication skills.

Responsibilities

• Lead investigations across multiple areas with cross-functional teams.
• Use structured root cause analysis tools (fishbone, 5 Whys) to identify baseline causes.
• Assess impact on product quality and safety; determine CAPA requirements.
• Draft and review SOPs; ensure GDP-compliant documentation.
• Prepare deviation reports for management and regulatory bodies.

Skills

Analytical thinking

Problem-solving

Regulatory knowledge

Excellent communication

Education

Bachelor’s degree in science (chemistry preferred)

Job description

Lonza Tampa is seeking a QA Deviation Specialist to identify, document, investigate, and resolve deviations and unplanned events in line with cGMPs and SOPs. The role requires collaboration with manufacturing, QA, maintenance, engineering, and supply chain to drive root-cause analyses and CAPA effectiveness.

You will author and review investigations, ensure timely closures, and support regulatory inspections and GDP-compliant documentation, contributing to product quality and patient safety.