GMP & CAPA Compliance Investigator

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 65,000 - 85,000; Full time

Job summary

Otsuka ICU Medical LLC is looking for a Compliance Investigator in Austin, Texas. The role involves investigating compliance issues and documenting findings to ensure adherence to regulatory standards.

You will coordinate quality system programs, manage investigations, and provide training related to compliance. The ideal candidate must have a Bachelor's Degree and at least 2 years of relevant experience in Quality or Manufacturing.

Qualifications

• Minimum of 2 years’ experience in Quality, Manufacturing, Engineering, or R&D functions.
• Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) preferred.
• Preferred experience in validation principles or pharmaceutical manufacturing methods.

Responsibilities

• Conduct investigations into process excursions and procedural exceptions.
• Ensure root cause and corrective action addressed in investigations.
• Document investigation results and manage corrective action plans.

Skills

Good Manufacturing Practices

Strong communication skills

Technical writing skills

Problem solving

Education

Bachelor’s Degree in Engineering, Science, or Manufacturing

Job description

Otsuka ICU Medical LLC is looking for a Compliance Investigator in Austin, Texas. The role involves investigating compliance issues and documenting findings to ensure adherence to regulatory standards.

You will coordinate quality system programs, manage investigations, and provide training related to compliance. The ideal candidate must have a Bachelor's Degree and at least 2 years of relevant experience in Quality or Manufacturing.