Quality Assurance Specialist III, Audits and Inspections

Job overview

The Quality Assurance Specialist III, Audits and Inspections role is onsite in Greenville, NC, with pay up to $45 per hour. It is a 12-month contract opportunity supporting a global biotechnology company's audit and inspection programs. The specialist helps maintain site quality compliance and readiness for regulatory reviews by supporting audits and inspections, monitoring program data, and tracking deviations, corrective and preventive actions, and health authority commitments. The work contributes to continuous improvement and timely completion of quality actions.

What you'll do

• Support scheduling, hosting, and responses for external client audits
• support mock and actual regulatory inspections
• track, trend, and analyze audit and inspection data
• monitor deviations, audit CAPAs, and health authority commitments
• define effectiveness checks for assigned audit CAPAs
• maintain program communications and critical documentation.

What we're looking for

Skills & competencies

quality assurance

audits and inspections

regulatory inspections

capa

pharmaceutical quality

medical devices

21 cfr

iso 13485

greenville nc

onsite

up to $45/hr

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, vision, and sick pay where applicable.

Why this role

Requires a bachelor's degree in a scientific, engineering, or health-related field, substantial pharmaceutical or medical-device quality experience, and knowledge of listed FDA regulations, ISO standards, and ICH guidance.

About the employer

Genesis10 is hiring for this role. Industry: Offices of Physicians (except Mental Health Specialists). Sector: 62.