Quality Investigator: CAPA, Investigations & Compliance

NCBioImpact; Raleigh (NC); Vor Ort; USD 70.000 - 100.000; Vollzeit

Zusammenfassung

Guerbet is seeking a Quality Investigator to conduct site investigations, identify root causes, and implement corrective and preventive actions to ensure regulatory and GMP compliance. You will support audits, trending, and continuous improvement efforts across the site.

The role requires a chemistry/biology/engineering background, 3–5 years in a regulated environment, and proficiency with SAP. This is a hands-on, cross-functional position based at our Raleigh facility.

Qualifikationen

• Bachelor's degree in chemistry, microbiology, biology, or engineering preferred.
• Other science-related degrees may be considered.
• Minimum 3–5 years’ experience in a pharmaceutical/ FDA‑regulated setting preferred.

Aufgaben

• Investigate and complete site-related minor and major investigations with coaching.
• Identify root causes and recommend CAPAs to address root cause.
• Perform Phase II OOS investigations.
• Support external audits from regulatory agencies and customers.
• Assist in trending metrics (Cost of Poor Quality, KPIs, QMRs, Data Trend Analysis).
• Support data compilation for site APRs.
• Participate in Kaizens or improvement initiatives.
• Revise SOPs as needed.
• Prepare GEMBA plans and conduct walks to drive compliance and safety.

Kenntnisse

SAP proficiency

Ausbildung

Bachelor's degree

Science degree considered

Tools

SAP

Jobbeschreibung

Guerbet is seeking a Quality Investigator to conduct site investigations, identify root causes, and implement corrective and preventive actions to ensure regulatory and GMP compliance. You will support audits, trending, and continuous improvement efforts across the site.

The role requires a chemistry/biology/engineering background, 3–5 years in a regulated environment, and proficiency with SAP. This is a hands-on, cross-functional position based at our Raleigh facility.