Quality Assurance Investigator: CAPA & Root Cause Lead

Accentuate Staffing; Raleigh (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical manufacturing recruiter is seeking a Quality Assurance Specialist for their QA Compliance team in Raleigh, NC. This role entails investigating deviations, conducting root cause analysis, and supporting regulatory audits. Ideal candidates will have a bachelor's degree in a relevant science field and at least 3 years of experience in FDA-regulated environments. Strong documentation skills and experience with quality systems are essential. Join to improve site compliance and performance in a cGMP environment.

Qualifications

• 3+ years of experience in pharmaceutical, biotech, or other FDA-regulated manufacturing environments.
• Experience with deviations, investigations, CAPA, OOS, and GMP quality systems.
• Ability to write investigation reports.

Responsibilities

• Investigate deviations ensuring timely completion of investigations.
• Perform root cause analysis and recommend CAPAs.
• Support regulatory and customer audits.

Skills

Root cause analysis

Documentation practices

Attention to detail

Collaboration

Education

Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering, or related science field

Tools

MS Office

SAP

Job description

A leading pharmaceutical manufacturing recruiter is seeking a Quality Assurance Specialist for their QA Compliance team in Raleigh, NC. This role entails investigating deviations, conducting root cause analysis, and supporting regulatory audits. Ideal candidates will have a bachelor's degree in a relevant science field and at least 3 years of experience in FDA-regulated environments. Strong documentation skills and experience with quality systems are essential. Join to improve site compliance and performance in a cGMP environment.