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SPECTRAFORCE · 17 hours ago

Compliance Analyst

Indianapolis, IN

Contract

Onsite

Senior Level

$40.86/hr - $40.86/hr

6+ years exp

SPECTRAFOR is seeking a highly skilled, experienced Senior QA Compliance Auditor to join their team on a contract-to-hire basis. This role supports clinical research drug development and offers commercial diagnostic laboratory testing services within a highly regulated setting.

ConsultingCRMInformation TechnologyLegal

Growth Opportunities

Hiring Manager

Sonali Dumka

Responsibilities

Plan, schedule, and conduct audits across the clinical laboratory, and operational support functions

Host and support sponsor-client audits and regulatory inspections

Perform external audits of suppliers and service providers

Support audit response development and CAPA implementation, ensuring responsiveness and delivery requirements are met for client and business stakeholders

Evaluate adherence to SOPs, regulatory requirements, and industry standards

Lead the response process for audits and inspections, including CAPA development, implementation and tracking

Monitor and drive closure of audit-related deliverables, ensuring timely completion and effectiveness

Support global QA policy implementation and interpretation of regulatory requirements

Ensure compliance with applicable regulations (GCP, ISO 15189, CAP, etc.) and internal quality standards

Participate in global quality initiatives to improve compliance and operational efficiency

Develop, deliver and participate in training on audit practices and compliance expectations

Promote a culture of quality and continuous improvement across teams

Prepare detailed audit reports with actionable recommendations

Track and report quality metrics, identifying trends and areas for improvement

Maintain audit records and ensure inspection readiness

Qualification

GCP complianceISO 15189ISO 13485Quality management systemsRegulatory inspectionsRisk-based auditingCAPA implementationInfluencing teamsVeeva proficiencyTrackWise proficiencyAudit reportingQuality metrics trackingCommunicationOrganizational skillsNegotiation skillsProblem-solving skillsIndependent workTeam collaboration