QA CAPA Investigator: Root Cause & Compliance

Pinnaql, Inc.; El Paso (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a QA CAPA Investigation Specialist to support quality investigations and corrective action activities in a regulated manufacturing environment.

You will conduct investigations, document CAPAs and nonconformances, perform root cause analysis, and collaborate with cross-functional teams to resolve quality issues. The role emphasizes thorough documentation, timely completion of investigations, and participation in trend analysis and audit readiness.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Manufacturing, or related technical field.
• Typically 3–5 years of FDA-regulated QA experience.
• Hands-on experience with CAPA, deviations, nonconformances, or quality investigations.
• Strong writing and documentation skills; able to analyze data and trends.
• Ability to manage multiple investigations and prioritize tasks.
• Experience with risk tools such as FMEA is a plus.

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 methods such as 5 Whys, Fishbone/Ishikawa.
• Identify root causes, contributing factors, and potential systemic issues.
• Prepare clear, accurate investigation reports.
• Support development and implementation of corrective and preventive actions.
• Track assigned CAPA and investigation activities through completion.
• Support effectiveness checks to verify implemented actions.
• Collaborate with cross-functional stakeholders to resolve open items and meet timelines.
• Review supporting documentation for objective evidence and rationale.
• Assist with trend analysis and identification of recurring quality issues.
• Support audit and regulatory inspection readiness as needed.
• Maintain complete documentation per procedures and regulatory requirements.

Skills

CAPA investigations

Root cause analysis

Quality systems

Technical writing

Cross-functional collaboration

Regulatory knowledge

Education

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

Tools

QMS software

FMEA

GMP compliance tools

Job description

Validation & Engineering Group, Inc. seeks a QA CAPA Investigation Specialist to support quality investigations and corrective action activities in a regulated manufacturing environment.

You will conduct investigations, document CAPAs and nonconformances, perform root cause analysis, and collaborate with cross-functional teams to resolve quality issues. The role emphasizes thorough documentation, timely completion of investigations, and participation in trend analysis and audit readiness.