Quality Assurance Specialist

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

Accentuate Staffing is partnering with a leading pharmaceutical manufacturing company who is hiring a Quality Assurance Specialist to join their QA Compliance team. This role will support deviation investigations, root cause analysis, CAPA development, and OOS investigations within a cGMP-regulated manufacturing environment. This is a great opportunity for someone who enjoys digging into quality events, identifying root cause, and driving corrective actions that improve overall site compliance and performance.

Responsibilities

1. Investigate minor, major, and critical deviations, ensuring timely and compliant completion of investigations
2. Perform root cause analysis and recommend CAPAs to prevent recurrence of quality issues
3. Conduct Phase II OOS investigations and support quality event documentation
4. Support regulatory and customer audits, including documentation review and audit readiness activities
5. Assist with quality metrics trending, APR data compilation, and KPI reporting
6. Participate in continuous improvement initiatives and Kaizen activities
7. Track investigation progress and report updates to management

Requirements

1. Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering, or related science field preferred
2. 3+ years of experience in pharmaceutical, biotech, or other FDA-regulated manufacturing environments
3. Experience with deviations, investigations, CAPA, OOS, and GMP quality systems
4. Strong documentation practices and experience writing investigation reports
5. Proficiency with MS Office and experience with systems such as SAP or electronic quality management systems is a plus
6. Strong attention to detail and ability to collaborate cross-functionally