Compliance Investigator: CAPA & GMP Excellence

Otsuka ICU Medical; Austin (TX); On-site; USD 85,000 - 115,000; Full time

Job summary

Otsuka ICU Medical is seeking a Compliance Investigator to lead investigations of process excursions and procedural exceptions, ensuring root cause analysis, CAPA and product impact are thoroughly documented. You will coordinate, write exception documents, and manage corrective actions while supporting audits and regulatory inspections.

Ideal candidates have a Bachelor's in Engineering/Science/Manufacturing with at least 2 years in Quality or Manufacturing and prefer CQE/CQA credentials.

Qualifications

• Bachelor's Degree in Engineering, Science, or Manufacturing, or other 4-year degree with commensurate experience.
• Minimum of 2 years' experience in Quality, Manufacturing, Engineering, or R&D functions.
• CQA or CQE preferred.
• Experience in validation principles; pharmaceutical manufacturing methods; documentation systems; quality systems; analytical or microbiological testing principles.

Responsibilities

• Investigate process excursions, procedural exceptions, and nonconforming events.
• Ensure root cause, CAPA, and product impact are addressed in investigations.
• Document investigation results and write exception documentation.
• Develop and manage corrective action plans and track effectiveness.
• Provide training and verification assessments for quality systems.
• Support GMP compliance during audits and regulatory reviews.
• Prepare departmental metrics and communicate status to management.
• Monitor GMP regulatory compliance activities during inspections.

Skills

GMP knowledge

Regulatory compliance

Technical writing

Communication

Education

Bachelor's Degree in Engineering/Science/Manufacturing

CQE or CQA preferred

Job description

Otsuka ICU Medical is seeking a Compliance Investigator to lead investigations of process excursions and procedural exceptions, ensuring root cause analysis, CAPA and product impact are thoroughly documented. You will coordinate, write exception documents, and manage corrective actions while supporting audits and regulatory inspections.

Ideal candidates have a Bachelor's in Engineering/Science/Manufacturing with at least 2 years in Quality or Manufacturing and prefer CQE/CQA credentials.