Compliance Specialist
Accentuate Staffing is partnering with a leading pharmaceutical manufacturer who is in search of a Compliance Specialist to join their team. This is a contract opportunity with the potential to convert to permanent, working fully onsite in a hands-on quality role. The ideal candidate is highly organized, detail-oriented, and experienced in FDA-regulated environments, with strong knowledge of CAPA management, electronic QMS systems, and cross-functional coordination.
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.
Requirements:
- 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.
