Quality Specialist III

About the role

Advance your career in Greenville, NC, as a Quality Specialist III with a top-tier global pharmaceutical leader. This fully on-site role leads site-wide compliance, executing robust internal and external audit programs and ensuring continuous inspection readiness for major regulatory agencies.

Location: Greenville, North Carolina
Job type: Contract
Education: Bachelor's degree

Responsibilities

• Support the scheduling, hosting, and resolution of external client audits and health authority inspections (e.g., FDA, EMA, MHRA).
• Drive inspection readiness through mock inspections, cross-functional collaboration, and SME coaching.
• Track, trend, and report quality metrics and KPIs directly to senior leadership to mitigate systemic risk.
• Oversee deviation resolution, audit CAPA completion, and health authority commitments within strict timelines.
• Define and monitor effectiveness checks for assigned CAPAs to eliminate root causes.
• Maintain critical quality documentation and record retention systems to support regulatory verification.

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).

Skills

• Good Manufacturing Practices (GMP)
• Corrective and Preventive Actions (CAPA)

Benefits

• Medical insurance
• Prescription coverage
• Dental insurance
• Vision insurance
• AD&D insurance
• Life insurance
• Short-term disability
• 401K plan

All benefits are based on eligibility.

Pay

$43 - $45 per hour

Schedule

9 to 5