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.
Qualifications
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.
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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.
Qualifications
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.
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