Accentuate Staffing · 6 hours ago
Compliance Specialist
Raleigh, NC
Full-time
Onsite
Mid Level
$35/hr - $45/hr
4+ years expAccentuate Staffing is partnering with a leading pharmaceutical manufacturer seeking a Compliance Specialist to join their team. The role involves tracking and assessing CAPA progress, coordinating with cross-functional stakeholders, and analyzing CAPA data to identify risks and trends.
Human ResourcesInformation TechnologyStaffing Agency
Hiring Manager
Emily Marohn
Responsibilities
Track, monitor, and assess CAPA progress to support site remediation efforts, ensuring adherence to approved timelines and milestones
Coordinate closely with cross-functional stakeholders (Production, QA, QC, Engineering, Validation, etc.) to drive timely completion of CAPA action items and hold owners accountable
Analyze CAPA data to identify delays, risks, trends, and performance gaps; escalate critical path issues as needed
Prepare and deliver daily updates on late or at-risk CAPAs and develop weekly progress summaries for leadership and executive steering committees
Qualification
Required
Experience working in an FDA-regulated pharmaceutical environment, with strong knowledge of CAPA processes, 21 CFR 210/211, and ICH Q9/Q10; exposure to terminal sterilization manufacturing and validation is preferred
Hands-on experience with electronic QMS platforms such as TrackWise, MasterControl, MetricStream, or similar systems for managing CAPAs and deviations
Strong organizational, coordination, and tracking skills with the ability to manage multiple CAPAs, monitor milestone adherence, and proactively follow up with stakeholders
Excellent analytical and documentation skills, including working knowledge of GDPs, ALCOA+, and data integrity requirements
Clear, professional communicator who can work independently, manage competing deadlines, and drive disciplined execution without direct people management responsibility
Bachelor's degree in Life Sciences or Engineering (preferred) with 4+ years of experience in an FDA-regulated industry, including at least 2 years in Quality with direct CAPA involvement
Preferred
Exposure to terminal sterilization manufacturing and validation is preferred
Bachelor's degree in Life Sciences or Engineering (preferred)
Company
Accentuate Staffing
Accentuate Staffing is a staffing and recruiting company offering local staffing solutions.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
George Apelian
Founder and Owner
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