Quality Specialist III

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

Job Summary

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 salary: $43 - 45 per hour work hours: 9 to 5 education: Bachelors

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

Required

• 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)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.