CAPA & QA Investigations Lead

Veg Group; El Paso (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

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

You will conduct investigations, perform root-cause analyses, and collaborate with cross-functional teams to ensure robust problem-solving and timely resolution. The role requires a Bachelor's degree in a technical field and 3–5 years in FDA-regulated QA, with strong technical writing and analytical skills.

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Manufacturing, or related field.
• Typically 3-5 years of experience in Quality Assurance, Quality Compliance, Investigations, CAPA, or related FDA-regulated roles.
• Hands-on experience conducting or supporting CAPAs, deviations, nonconformances, or quality investigations.
• Strong technical writing and documentation 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 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

Root cause analysis

Technical writing

Cross-functional collaboration

Quality investigations

Analytical skills

Documentation

Education

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

Tools

eQMS (electronic Quality Management System)

FMEA tools

Regulatory documentation software

Job description

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

You will conduct investigations, perform root-cause analyses, and collaborate with cross-functional teams to ensure robust problem-solving and timely resolution. The role requires a Bachelor's degree in a technical field and 3–5 years in FDA-regulated QA, with strong technical writing and analytical skills.