Quality Deviation Investigator

Lonza; Tampa (FL); On-site; Confidential; Full time

Job summary

Lonza Tampa is seeking a QA Deviation Specialist to lead investigations into deviations and unplanned events, ensuring compliance with cGMPs and regulatory requirements.

You will collaborate with manufacturing, quality control, maintenance, and supply chain to determine root causes, implement CAPAs, and prepare deviation reports for management and regulatory bodies. A Bachelor's degree in science and 3 years QA experience are required.

Qualifications

• Bachelor's degree in science; 3+ years in quality assurance or deviation management; knowledge of regulatory requirements (FDA/EMA/ISO).
• Strong analytical and problem-solving skills, with excellent communication and interpersonal abilities.
• Experience leading investigations, root-cause analysis, and CAPA effectiveness assessments.

Responsibilities

• Lead investigations into deviations and unplanned events across multiple areas.
• Collaborate with manufacturing, quality control, maintenance, engineering, and supply chain to determine root causes and implement improvements.
• Perform structured root cause analysis (fishbone, 5 Why) and assess impact on product quality and safety.
• Prepare and present deviation reports to management and regulatory authorities.
• Ensure documentation adheres to Good Documentation Practices (GDP) and supports regulatory inspections.

Skills

Quality assurance

Root cause analysis

Cross-functional collaboration

Regulatory knowledge

Analytical thinking

Education

Bachelor's degree in science

Job description

Lonza Tampa is seeking a QA Deviation Specialist to lead investigations into deviations and unplanned events, ensuring compliance with cGMPs and regulatory requirements.

You will collaborate with manufacturing, quality control, maintenance, and supply chain to determine root causes, implement CAPAs, and prepare deviation reports for management and regulatory bodies. A Bachelor's degree in science and 3 years QA experience are required.