Quality Assurance Specialist III

Job overview

The Quality Assurance Specialist III role is onsite in Research Triangle Park, NC. Compensation is $30–$40 per hour. The position provides quality assurance oversight and auditing for clinical and preclinical studies and reports to the Quality Assurance Manager (GCP/GLP). The specialist audits studies, processes, records, and data to assess compliance with protocols and applicable regulations. The role helps identify and follow up on findings, supports staff with compliance questions, and contributes to quality oversight of laboratory research activities.

What you'll do

• Provide QA oversight and audit clinical and preclinical study activities
• assess compliance with protocols, controlled documents, regulations, and guidelines
• audit studies, processes, reports, records, and data and follow up on findings
• perform in-process inspections of nonclinical study phases and assay methods
• serve as a technical resource on compliance matters
• perform other duties assigned by Quality Assurance Management.

What we're looking for

Skills & competencies

quality assurance specialist iii

research triangle park nc

onsite

$30–$40/hr

clinical studies

preclinical studies

auditing

glp

gclp

21 cfr part 11

ddpcr

Work arrangement

• Weekend coverage required

Why this role

Requires audit experience and robust knowledge of immunogenicity (NAb and TAb) and ddPCR assays; GCP knowledge is a plus but not required.

About the employer

Leadstack Inc is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.