Audit-Ready Source Quality Specialist

Johnson & Johnson MedTech; Cornelia (GA); On-site; USD 94,000 - 152,000; Full time

Benefits offered by this job

Vacation 120 hours per year

Sick time 40 hours per year

Floating holidays 13 days per year

Parental Leave 480 hours

Job summary

Johnson & Johnson MedTech seeks a Staff Source Compliance Specialist to establish and maintain a robust compliance program across multiple sites (Guaynabo PR; Cornelia GA; Raritan NJ; San Angelo TX). You will lead audit readiness, drive regulatory alignment, and partner with leadership to ensure timely responses to regulatory findings.

The role requires a bachelor’s degree in engineering or related field, 4+ years in a regulated industry, GMP documentation experience, and strong English

Qualifications

• Bachelor’s degree in engineering, applied science or related technical field.
• Minimum 4 years in a highly regulated industry is required.
• GMP documentation experience and writing skills in FDA-regulated environment are required.
• 2+ years external audit readiness/management preferred.
• Strong English communication skills (written and oral).

Responsibilities

• Lead internal/external audit readiness activities including logistics and SME preparation.
• Support audits by Notified Bodies, Health Authorities, FDA and regulators.
• Provide timely information for audit/inspection processes and communicate findings.
• Coordinate responses to audit observations, including CAPA and corrective actions.
• Represent sourcing compliance in sector and enterprise teams/projects.

Skills

Communications

Education

Bachelor's degree in engineering or related field

Job description

Johnson & Johnson MedTech seeks a Staff Source Compliance Specialist to establish and maintain a robust compliance program across multiple sites (Guaynabo PR; Cornelia GA; Raritan NJ; San Angelo TX). You will lead audit readiness, drive regulatory alignment, and partner with leadership to ensure timely responses to regulatory findings.

The role requires a bachelor’s degree in engineering or related field, 4+ years in a regulated industry, GMP documentation experience, and strong English