Senior Quality Auditor, Regulatory Readiness & CAPA Lead

Randstad USA; Greenville (NC); On-site; USD 59,000 - 62,000; Full time

Job summary

Randstad USA is seeking a Quality Specialist III for an on-site role in Greenville, NC. You will lead site-wide audit programs and ensure readiness for major regulatory inspections, including FDA/EMA/MHRA, while driving risk-based quality improvements.

Responsibilities include coordinating external audits, tracking quality metrics, and overseeing CAPA resolutions. Requires a Bachelor's in a scientific field, 8+ years of quality experience in pharma/medical devices, and expertise in 21 CFRs and

Qualifications

• Bachelor's degree in a scientific, engineering, or health-related field.
• 8+ years of quality experience in the pharmaceutical or medical device industry.
• 5+ years of broad pharmaceutical or medical device industry experience.
• Expert working knowledge of 21 CFR 210/211, 21 CFR 600, 21 CFR 820, ISO 13485, ISO 9001, and ICH Q9/Q10.
• Proficient with electronic quality management systems (TrackWise, Documentum, Veeva Vault).

Responsibilities

• Support external client audits and health authority inspections scheduling and hosting.
• Drive inspection readiness through mock inspections and SME coaching.
• Track, trend, and report quality metrics and KPIs to senior leadership.
• Oversee deviation resolution, audit CAPA completion, and health authority commitments.
• Define and monitor effectiveness checks for CAPAs to prevent root causes.
• Maintain quality documentation and record retention to support regulatory verification.

Skills

GMP

CAPA

Education

Bachelor's degree in a scientific/engineering/health field

Tools

TrackWise

Documentum

Veeva Vault

Job description

Randstad USA is seeking a Quality Specialist III for an on-site role in Greenville, NC. You will lead site-wide audit programs and ensure readiness for major regulatory inspections, including FDA/EMA/MHRA, while driving risk-based quality improvements.

Responsibilities include coordinating external audits, tracking quality metrics, and overseeing CAPA resolutions. Requires a Bachelor's in a scientific field, 8+ years of quality experience in pharma/medical devices, and expertise in 21 CFRs and