Complaint QA Lead: Investigation & Approval

Johnson & Johnson Co.; Gurabo (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Johnson & Johnson in Gurabo, Puerto Rico, seeks a Complaint Quality Approver to independently review investigations and approve records for site-manufactured products. You will ensure root cause is justified, data integrity is maintained, and actions are tracked, partnering with cross-functional teams to maintain cGMP compliance.

The role requires a Bachelor’s in Life Science and at least 4 years of quality investigations experience, with strong documentation and risk-management skills, onsite

Qualifications

• Bachelor’s degree in Life Science or related discipline is required.
• Minimum of 4 years of experience performing and/or reviewing quality investigations (complaints, deviations, nonconformances, or similar quality events).
• Experience with quality systems and regulatory requirements.
• Strong writing, concise documentation, and actionable feedback.
• cGMP and Good Documentation Practices familiarity; GMP expectations for pharmaceuticals/medical products.
• Ability to assess risk, escalation, and action alignment across sites.
• Clear written communication and data review skills.

Responsibilities

• Review complaint records throughout investigation lifecycle and provide final QA approval before closure.
• Ensure investigation strategy alignment and appropriate Root Cause Analysis.
• Verify use of correct investigation tools and involvement of stakeholders across functions.
• Provide coaching on CAPA best practices and system usage.
• Verify actions are defined, owned, and tracked before approval of records.

Skills

Quality investigations

Documentation

Regulatory knowledge

Analytical thinking

Risk assessment

Communication

Teamwork

Independence

Education

Bachelor’s degree in Life Science

Tools

PQMS / QMS systems

Job description

Johnson & Johnson in Gurabo, Puerto Rico, seeks a Complaint Quality Approver to independently review investigations and approve records for site-manufactured products. You will ensure root cause is justified, data integrity is maintained, and actions are tracked, partnering with cross-functional teams to maintain cGMP compliance.

The role requires a Bachelor’s in Life Science and at least 4 years of quality investigations experience, with strong documentation and risk-management skills, onsite