Quality Specialist III: Audit & Inspection Expert

ManpowerGroup; Greenville (NC); On-site; USD 52,000 - 72,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

401(k) Plus Match

Weekly Pay

Job summary

ManpowerGroup is seeking a Quality Specialist III for a leading pharmaceutical and medical device organization in Greenville, NC. The role focuses on audits, inspections, and regulatory readiness to ensure quality compliance across programs.

The ideal candidate has strong collaboration skills, deep QA experience in pharma/medical devices, and hands-on expertise with 21 CFR, ICH Q9/Q10, and QMS systems like Documentum, Veeva Vault, TrackWise.

Qualifications

• Bachelor's degree in a scientific, engineering, or health-related field.
• 5+ years in pharma/medical device quality.
• 8+ years in quality with deviation mgmt, GMP/QA, or related areas.
• Knowledge of 21 CFR Part 210/211, Part 600, Part 820 QMSR, ISO 13485, ISO 9001, ICH Q9/Q10.
• Experience with electronic QMS systems: Documentum, Veeva Vault, TrackWise.

Responsibilities

• Execute and maintain internal, client audits and regulatory inspections programs.
• Coordinate external audit preparation, scheduling, hosting, and timely responses to findings.
• Support inspection readiness with mock and regulatory inspections by health authorities (FDA, EMA, ANVISA, MHRA).
• Track, trend, and analyze audit data and quality issues to drive improvements.
• Monitor deviations and CAPAs, ensure timely responses and effectiveness checks.

Skills

Audits & Inspections

Cross-functional Collaboration

Documentation & QA

Communication

Problem Solving

Education

Bachelor's degree in science/engineering/health

Tools

Documentum

Veeva Vault

TrackWise

Job description

ManpowerGroup is seeking a Quality Specialist III for a leading pharmaceutical and medical device organization in Greenville, NC. The role focuses on audits, inspections, and regulatory readiness to ensure quality compliance across programs.

The ideal candidate has strong collaboration skills, deep QA experience in pharma/medical devices, and hands-on expertise with 21 CFR, ICH Q9/Q10, and QMS systems like Documentum, Veeva Vault, TrackWise.