Lead Deviation Investigator — Viral Vector QA

Lonza Inc.; Houston (TX); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Performance bonus

Medical/dental/vision insurance

401(k) matching

Life insurance

Disability insurance

Employee assistance program

Paid time off

Job summary

Lonza Inc. on-site in Houston, TX seeks a Deviation Investigation Writer - Viral Vector to lead and execute investigations in a cGMP viral vector manufacturing environment.

You will independently manage minor and low-to-medium severity investigations while supporting higher-risk cases, identifying root causes, assessing quality impact, and implementing CAPAs. You will partner with Manufacturing, Quality Assurance, and MSAT to ensure quality records are accurate, compliant, and timely,

Qualifications

• Experience in deviation investigations and quality systems.
• Bachelor's degree preferred; science discipline.
• Strong RCA, CAPA, risk assessments, and investigations.
• Strong technical writing to convey events clearly.
• Ability to work independently and manage multiple investigations.
• Familiarity with cGMP and SOPs/batch records.
• Excellent communication and cross-functional collaboration.
• Experience in biopharma/viral vector environments preferred.

Responsibilities

• Lead and independently manage deviation investigations, ensuring timely initiation, investigation, documentation, and closure of quality records.
• Author clear, concise, and technically accurate investigation reports for internal and external stakeholders.
• Gather and evaluate data from manufacturing, laboratory, engineering, and quality systems to support investigations.
• Perform RCA, cause mapping, risk assessments, and trending analyses to identify root causes and improvement opportunities.
• Assess events for SISQP impact and support PQI determinations.
• Develop and implement CAPAs to reduce recurrence risk.
• Manage multiple investigations and priorities while meeting KPIs and regulatory timelines.
• Facilitate cross-functional investigation meetings and drive timely decisions.

Skills

Deviation investigations

Quality systems

Root Cause Analysis

CAPA development

Technical writing

SOPs interpretation

Data analysis

Cross-functional collaboration

TrackWise

Education

Associate degree in science

Bachelor's degree preferred

Tools

TrackWise

Microsoft Office

LIMS experience

Job description

Lonza Inc. on-site in Houston, TX seeks a Deviation Investigation Writer - Viral Vector to lead and execute investigations in a cGMP viral vector manufacturing environment.

You will independently manage minor and low-to-medium severity investigations while supporting higher-risk cases, identifying root causes, assessing quality impact, and implementing CAPAs. You will partner with Manufacturing, Quality Assurance, and MSAT to ensure quality records are accurate, compliant, and timely,