Quality Specialist III, Audits and Inspections

Job overview

The Quality Specialist III, Audits and Inspections role is onsite in Greenville, NC. Compensation is not specified. The position supports the Audits and Inspections program by helping maintain compliance and inspection readiness for regulatory agency reviews. The specialist coordinates audit and inspection activities, tracks quality metrics and issues, and monitors corrective actions and effectiveness checks. The role helps identify systemic risks, maintain critical records, and support continuous improvement across audit and inspection processes.

What you'll do

• Support scheduling, hosting, and responses for external client audits
• support mock and actual regulatory inspections involving agencies such as FDA, EMA, ANVISA, and MHRA
• track, trend, and analyze audit, inspection, and quality-issue data
• report audit and inspection KPIs
• monitor deviations, audit CAPAs, and health authority commitments for timely completion and submission
• ensure appropriate effectiveness checks
• communicate to support program participation and improvement
• maintain documentation and records for audits and inspections.

What we're looking for

Skills & competencies

quality specialist iii

audits and inspections

quality assurance

regulatory inspections

capa

gmp

21 cfr

iso 13485

greenville nc

onsite

pharmaceutical industry

medical device industry

Work arrangement

• Weekend coverage required

Why this role

The posting describes a 12-month W-2 contract with a high possibility of extension based on performance and business needs; requires a bachelor’s degree and substantial pharmaceutical or medical-device quality experience.

About the employer

Integrated Resources, Inc is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.