Senior QA Investigator & CAPA Leader

Johnson & Johnson Co.; Raritan (NJ); On-site; USD 94,000 - 152,000; Full time

Benefits offered by this job

Vacation 120 hours/yr

Sick time 40 hours/yr

Holiday pay 13 days/yr

Parental Leave 480 hours

Volunteer Leave 32 hours/yr

401(k) plan

Job summary

Johnson & Johnson is seeking a Sr. Quality Specialist in Quality Assurance to lead investigation robustness, root-cause analysis, and corrective actions. You will monitor progress, provide coaching, and escalate issues to senior management as needed, ensuring timely closure of records.

The role requires a strong background in regulated environments, CAPA systems, and data-driven quality improvements, with excellent communication skills for executive summaries and reporting.

Qualifications

• Bachelor's Degree or equivalent; Life Science preferred.
• Minimum of 6 years' experience in a regulated field and/or investigations.
• Experience in investigation-related functions; familiarity with CAPA systems.
• Excellent communication and writing skills; ability to develop clear professional correspondence.
• Strong analytical and problem-solving abilities; ability to collaborate across the organization.

Responsibilities

• Execute quality reviewer/approver duties; review evidence and approve closure of investigation records.
• Conduct investigation record quality reviews for documentation completeness and robust root-cause analysis.
• Provide coaching and feedback to issue owners on best practices and investigation execution.
• Monitor progress of investigations; track actions and approvals; escalate as needed.
• Collaborate with stakeholders to support end-to-end investigation processes and ensure corrective actions are effective.

Skills

Investigation experience

CAPA systems

Data analysis

Regulatory compliance

Excellent written communication

Education

Bachelor's Degree or equivalent (Life Science preferred)

Job description

Johnson & Johnson is seeking a Sr. Quality Specialist in Quality Assurance to lead investigation robustness, root-cause analysis, and corrective actions. You will monitor progress, provide coaching, and escalate issues to senior management as needed, ensuring timely closure of records.

The role requires a strong background in regulated environments, CAPA systems, and data-driven quality improvements, with excellent communication skills for executive summaries and reporting.