Audit-Ready Source Quality Specialist

Antler; San Angelo (TX); On-site; USD 94,000 - 152,000; Full time

Job summary

Johnson & Johnson is seeking a Staff Source Compliance Specialist to establish and maintain a robust compliance program across sites in PR, GA, NJ, and TX. You will lead audits and drive CAPA in alignment with Source Quality global requirements.

The role requires GMP and FDA-regulated experience, strong English communication, and collaboration with cross-site teams to ensure timely regulatory responses and continuous improvement.

Qualifications

• Bachelor's degree in engineering, Applied Science or related quality field.
• At least 4 years of work experience in a highly regulated Industry.
• GMP documentation experience in FDA regulated environment.
• At least 2 years of external audit readiness and management (preferred).
• Source quality or procurement experience (preferred).
• Strong English communication (written and oral).

Responsibilities

• Lead and manage internal/external audit readiness activities to ensure readiness.
• Partner with site leadership to support internal/external audits (Notified Body, Health Authority, FDA, etc.).
• Provide timely information to support the audit/inspection process.
• Ensure external audit results are reported to management and communicate potential non-conformities.
• Provide guidance to prepare responses to regulatory notifications.
• Ensure timely responses to audit observations and corrective actions.
• Provide compliance representation on site teams/projects as appropriate.
• Support deployment of Quality System standards at sites.
• Collaborate with compliance teams across sites and regions.
• Escalate quality issues per procedures.
• Communicate compliance trends and initiatives to management.

Skills

Quality compliance

Audit readiness

Regulatory knowledge

English communication

Education

Bachelor's degree in engineering or related quality field

Job description

Johnson & Johnson is seeking a Staff Source Compliance Specialist to establish and maintain a robust compliance program across sites in PR, GA, NJ, and TX. You will lead audits and drive CAPA in alignment with Source Quality global requirements.

The role requires GMP and FDA-regulated experience, strong English communication, and collaboration with cross-site teams to ensure timely regulatory responses and continuous improvement.