CAPA & Compliance Specialist - FDA QMS (Onsite)

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

Job summary

A leading recruitment firm is partnering with a pharmaceutical manufacturer to find a Compliance Specialist in Raleigh, North Carolina. This contract role focuses on managing CAPA processes in an FDA-regulated environment. Ideal candidates will have a Bachelor’s degree in Life Sciences or Engineering and over 4 years of experience, with strong knowledge of CAPA management and electronic QMS platforms. Responsibilities include tracking CAPA progress and coordinating across departments to ensure compliance with quality standards.

Qualifications

• 4+ years of experience in an FDA-regulated industry, including 2 years in Quality with CAPA involvement.
• Hands-on experience with electronic QMS platforms for managing CAPAs and deviations.
• Strong knowledge of CAPA processes, 21 CFR 210/211, ICH Q9/Q10.

Responsibilities

• Track, monitor, and assess CAPA progress to ensure adherence to timelines.
• Coordinate with cross-functional teams to drive completion of CAPA action items.
• Analyze CAPA data to identify delays and escalate critical path issues.

Skills

FDA regulatory knowledge

CAPA management

Analytical skills

Organizational skills

Communication skills

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

TrackWise

MasterControl

MetricStream

Job description

A leading recruitment firm is partnering with a pharmaceutical manufacturer to find a Compliance Specialist in Raleigh, North Carolina. This contract role focuses on managing CAPA processes in an FDA-regulated environment. Ideal candidates will have a Bachelor’s degree in Life Sciences or Engineering and over 4 years of experience, with strong knowledge of CAPA management and electronic QMS platforms. Responsibilities include tracking CAPA progress and coordinating across departments to ensure compliance with quality standards.