Compliance Specialist

Stefanini Group•Raleigh, NC
•Onsite

About The Position

The Business Compliance Specialist supports business compliance remediation, audit readiness, documentation quality, and process adherence by partnering with business teams and Quality Assurance & Regulatory Affairs (QARA). The role helps ensure records, supporting documentation, training evidence, and operational processes are complete, accurate, organized, and ready for review. It operates within the business organization and works with QARA to strengthen compliance controls, reduce risk, support ongoing intake, and improve audit readiness. The specialist reviews compliance and project documentation, installation and product records, training records, and supporting materials for completeness, accuracy, and alignment with internal procedures, documentation standards, and applicable regulatory expectations. The role also supports change management, audit preparation, documentation maintenance, issue follow-up, reporting, process adherence, and continuous improvement. It works with Project Operations, Project Managers, Order Management, Commercial, Finance, Procurement, and technology partners.

Requirements

  • Bachelor's degree in Business Administration, Quality, Compliance, Operations, Healthcare Administration, Finance, Accounting, or a related field.
  • Experience supporting business compliance, quality review, project operations, audit readiness, documentation control, or regulated business processes.
  • Strong attention to detail and ability to review records for completeness, consistency, and accuracy.
  • Ability to define problems, identify practical solutions, and follow through to completion.
  • Proficiency with Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams.
  • Ability to use Excel to organize information, review data, track open items, and support reporting needs.
  • Intermediate Excel skills, including XLOOKUP, sorting and filtering data, and creating pivot tables.
  • Clear written and verbal communication skills and ability to work across multiple teams.
  • Strong organization skills and ability to manage competing priorities and tight timelines.
  • Comfort working with process documents, checklists, training records, audit evidence, and issue logs.
  • Professional judgment, confidentiality, and ability to escalate risks or gaps appropriately.

Responsibilities

  • Conduct standard reviews of submitted compliance documentation for adherence to internal procedures, documentation standards, and applicable regulatory expectations.
  • Review project documentation, installation records, product-related documentation, training records, and supporting materials for completeness, accuracy, and audit readiness before submission to QARA or business review processes.
  • Represent business operations in change-management discussions, provide operational supporting documentation updates, and help ensure implementation activities align with established QARA guidance.
  • Partner with QARA to prepare for internal and external audits by confirming records, training evidence, process documentation, and supporting materials are complete and organized.
  • Maintain, organize, and update compliance-related records, checklists, process documents, meeting notes, action logs, and supporting documentation.
  • Identify documentation gaps, process risks, control deficiencies, or compliance concerns and coordinate follow-up actions through closure with appropriate business owners.
  • Collaborate with Project Operations, Project Managers, Order Management, Commercial, Finance, Procurement, and technology partners to promote clear handoffs and consistent compliance practices.
  • Provide updates on compliance review progress, backlog remediation activities, open risks, documentation gaps, issue resolution status, and audit-readiness actions.
  • Support updates to work instructions, checklists, and training materials to improve consistency, reduce rework, and strengthen operational controls.
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