GMP Compliance Investigator & CAPA Lead

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 70,000 - 110,000; Full time

Job summary

Otsuka ICU Medical LLC seeks a Compliance Investigator to conduct investigations into process excursions and procedural exceptions, ensuring CAPA and product impact are addressed. You will document results, develop corrective actions, and support audits.

The role requires GMP/regulatory knowledge, strong writing and communication skills, and at least 2 years in quality or manufacturing fields. Travel is minimal, with emphasis on maintaining compliance across systems.

Qualifications

• Bachelor's Degree required in Engineering, Science or Manufacturing (other 4yr degrees considered with commensurate experience).
• Minimum of 2 years in Quality, Manufacturing, Engineering, or R&D preferred.
• CQA or CQE preferred.

Responsibilities

• Conduct investigations into process excursions, procedural exceptions and nonconforming events.
• Ensure root cause, CAPA, and product impact are thoroughly addressed in investigations.
• Document investigations results and manage corrective action plans for exceptions.

Skills

Communication skills

Technical writing

Organizational skills

Regulatory knowledge

Education

Bachelor's Degree in Engineering/Science/Manufacturing

CQE preferred

Tools

CQE tools

Job description

Otsuka ICU Medical LLC seeks a Compliance Investigator to conduct investigations into process excursions and procedural exceptions, ensuring CAPA and product impact are addressed. You will document results, develop corrective actions, and support audits.

The role requires GMP/regulatory knowledge, strong writing and communication skills, and at least 2 years in quality or manufacturing fields. Travel is minimal, with emphasis on maintaining compliance across systems.