QA Investigations Lead - CAPA & Root Cause Analysis

Socket.dev; Austin (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Otsuka ICU Medical in Austin, TX seeks an Investigations Specialist to review and approve nonconformances, assess impact, determine root cause, and identify CAPAs to prevent repeats. You will track events and CAPAs to ensure timely closure and maintain compliance with FDA and corporate policies.

The role collaborates with Quality, Operations and Regulatory/Compliance, writes technical summaries, organizes data, and ensures timely approvals of records.

Qualifications

• Bachelor's degree in a scientific discipline (Chemistry, Biology, Microbiology, or Engineering) required.
• 4–6 years' experience in Quality, Manufacturing, Engineering, or R&D functions or combinations.
• Experience in a regulated industry; Pharmaceutical preferred.

Responsibilities

• Review and approve nonconformances and investigation reports; ensure timely closure.
• Assist with development of investigational plans and root cause determination; identify CAPAs.
• Organize data, extract key information, and write technical summary reports.

Skills

FDA regulations

Quality tools

Technical writing

Oral & written communication

Interpersonal skills

Facilitation/presentation

Microsoft Office

Education

Bachelor's degree in Chemistry, Biology, Microbiology, or Engineering

Tools

Microsoft Word

Excel

PowerPoint

Investigations systems

Job description

Otsuka ICU Medical in Austin, TX seeks an Investigations Specialist to review and approve nonconformances, assess impact, determine root cause, and identify CAPAs to prevent repeats. You will track events and CAPAs to ensure timely closure and maintain compliance with FDA and corporate policies.

The role collaborates with Quality, Operations and Regulatory/Compliance, writes technical summaries, organizes data, and ensures timely approvals of records.