QA CAPA Investigator: Root-Cause & Compliance Lead

Veg Group; El Paso (TX); Hybrid; USD 65,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a QA CAPA Investigation Specialist to support quality investigations and corrective actions in a regulated manufacturing setting.

You will conduct and document investigations, perform root cause analysis, and collaborate with cross-functional teams to ensure accurate, evidence-based conclusions and effective CAPAs. You will gather data, prepare investigation reports, track CAPA activities through completion, and assist with trend analysis and

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Manufacturing, or a related technical discipline.
• Typically 3-5 years of experience in Quality Assurance, Quality Compliance, Investigations, CAPA, or a related function within an FDA-regulated industry.
• Hands-on experience conducting or supporting CAPAs, deviations, nonconformances, or quality investigations.
• Working knowledge of structured root cause analysis and problem-solving methodologies.
• Strong technical writing and documentation skills.
• Strong analytical and organizational skills.
• Ability to manage multiple investigations and priorities simultaneously.
• Effective written and verbal communication skills.
• Ability to work collaboratively with cross-functional teams.

Responsibilities

• Conduct and document quality investigations, CAPAs, nonconformances, and related quality events.
• Gather and analyze relevant data, records, and supporting documentation.
• Perform structured root cause analysis using tools such as 5 Whys, Fishbone/Ishikawa, and other problem-solving methodologies.
• Identify root causes, contributing factors, and potential systemic issues.
• Prepare clear, accurate, and technically sound investigation reports.
• Support the development and implementation of corrective and preventive actions.
• Track assigned CAPA and investigation activities through completion.
• Support effectiveness checks to verify that implemented actions achieved the intended results.
• Collaborate with cross-functional stakeholders to obtain information, resolve open items, and complete investigations within established timelines.
• Review supporting documentation to ensure conclusions are based on objective evidence and appropriate technical rationale.
• Assist with trend analysis and identification of recurring quality issues.
• Support audit and regulatory inspection readiness activities as needed.
• Maintain complete and timely documentation in accordance with applicable procedures and regulatory requirements.

Skills

CAPA investigations

Root cause analysis

Quality Assurance

Documentation

Cross-functional collaboration

Data analysis

Strong writing skills

Regulatory understanding

Project management

Communication

Education

Bachelor's degree in Engineering, Science, Quality, Manufacturing

Tools

eQMS software

FMEA risk tools

Job description

Validation & Engineering Group, Inc. is seeking a QA CAPA Investigation Specialist to support quality investigations and corrective actions in a regulated manufacturing setting.

You will conduct and document investigations, perform root cause analysis, and collaborate with cross-functional teams to ensure accurate, evidence-based conclusions and effective CAPAs. You will gather data, prepare investigation reports, track CAPA activities through completion, and assist with trend analysis and