Senior QA Investigations & CAPA Specialist

6062-Janssen Pharmaceuticals, Inc. Legal Entity; Raritan (NJ); Sur place; USD 94 000 - 152 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Long-term incentive program

Paid time off

Résumé du poste

Johnson & Johnson in Raritan, New Jersey seeks a Sr. Quality Specialist to lead robustness of investigations and approvals, ensuring timely triage, thorough root-cause analysis, and effective corrective actions.

The role supports monitoring progress, provides feedback to owners, and elevates issues to senior management when needed. Responsibilities include reviewing investigations, coaching issue owners, and ensuring compliance with procedures.

Qualifications

• Bachelor’s Degree or equivalent is required, Life Science or related discipline preferred.
• Knowledge and experience with regulations and regulatory compliance issues.
• Minimum of 6 years’ experience in a regulated field and/or equivalent experience/training in an investigations capacity.
• Demonstrated experience in an investigation related function.

Responsabilités

• Lead robustness of investigations and approvals, ensuring timely triage and root-cause analysis.
• Provide coaching and actionable feedback to investigation owners.
• Monitor action progress and approvals, elevate risks when needed.
• Collaborate with stakeholders to support end-to-end investigation process.
• Use data analytics and trending to identify failure modes and inform improvements.

Connaissances

Root cause analysis

Investigations

Quality approvals

Data analysis

Cross-functional collaboration

Formation

Bachelor’s Degree or equivalent (Life Science or related)

Description du poste

Johnson & Johnson in Raritan, New Jersey seeks a Sr. Quality Specialist to lead robustness of investigations and approvals, ensuring timely triage, thorough root-cause analysis, and effective corrective actions.

The role supports monitoring progress, provides feedback to owners, and elevates issues to senior management when needed. Responsibilities include reviewing investigations, coaching issue owners, and ensuring compliance with procedures.