QA CAPA Investigator — Root Cause & Compliance

Pinnaql, Inc.; El Paso (TX); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a QA CAPA Investigation Specialist to support quality investigations and CAPA activities in a regulated manufacturing environment.

You will perform root cause analysis using tools such as 5 Whys and Ishikawa, document investigations, and collaborate with cross-functional teams to ensure timely closure and effective corrective actions.

Qualifications

• Bachelor’s degree in Engineering, Science, Quality, Manufacturing, or 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.

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 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 implemented actions achieved desired results.
• Collaborate with cross-functional stakeholders to resolve open items and meet timelines.
• Review supporting documentation to ensure conclusions are evidence-based.
• Assist with trend analysis and identification of recurring quality issues.
• Support audit and regulatory inspection readiness activities as needed.
• Maintain complete documentation per procedures and regulatory requirements.

Skills

Root cause analysis

CAPA investigations

Quality documentation

FDA regulations

Written & verbal communication

Cross-functional collaboration

Prioritization of investigations

Education

Bachelor’s degree in Engineering, Science, Quality or related discipline

Tools

eQMS (Electronic Quality Management System)

Job description

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a QA CAPA Investigation Specialist to support quality investigations and CAPA activities in a regulated manufacturing environment.

You will perform root cause analysis using tools such as 5 Whys and Ishikawa, document investigations, and collaborate with cross-functional teams to ensure timely closure and effective corrective actions.