Audit-Ready Source Quality Specialist

Antler; Guaynabo (PR); On-site; USD 94,000 - 152,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) and pension plan

Paid time off and holidays

Job summary

Johnson & Johnson is seeking a Staff Source Compliance Specialist to establish and maintain a robust compliance program for Purchasing Controls. The role reports to the Source Quality System Lead and acts as the SPOC for Audit Readiness and Audit Support across the Source Quality global team.

The position requires a bachelor’s degree in a technical/quality field, 4+ years in a regulated industry, GMP documentation experience, and strong English communication.

Qualifications

• Bachelor's degree in engineering or related quality field.
• 4 years of work experience in highly regulated industry.
• GMP documentation experience in FDA-regulated environment.
• At least 2 years of external audit readiness/management experience preferred.
• Source Quality or Procurement experience preferred.
• Strong English communication (written and oral).

Responsibilities

• Lead internal/external audit readiness activities and logistics.
• Support site leadership for internal/external audits and regulatory inspections.
• Provide timely information to support audit/inspection processes.
• Escalate deviations and observations to management with clear action plans.
• Prepare responses to audit notifications and regulatory inquiries.
• Drive corrective actions and verify effectiveness of CAPA plans.
• Collaborate with site teams and regional compliance groups.

Skills

Audit readiness

English proficiency

Education

Bachelor's degree in engineering, Applied Science or related quality field

Job description

Johnson & Johnson is seeking a Staff Source Compliance Specialist to establish and maintain a robust compliance program for Purchasing Controls. The role reports to the Source Quality System Lead and acts as the SPOC for Audit Readiness and Audit Support across the Source Quality global team.

The position requires a bachelor’s degree in a technical/quality field, 4+ years in a regulated industry, GMP documentation experience, and strong English communication.