QA & Regulatory Compliance Associate

Position Title: QA & Regulatory Compliance Associate

Work Location: 1501 Nowell Rd, Raleigh, NC, 27607

Assignment Duration: 12 Months

Work Arrangement: Onsite

Business Compliance Specialist

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). This role helps ensure records, supporting documentation, training evidence, and operational processes are complete, accurate, organized, and ready for review.

• This position operates within the business organization and works with QARA to strengthen compliance controls, reduce risk, support ongoing intake, and improve audit readiness

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

Success in this role looks like

• Compliance checks are completed consistently and documented clearly.
• Records submitted for review are complete, accurate, and easy to validate.
• Audit preparation materials are organized, current, and ready when needed.
• Process gaps are identified early and tracked through closure.
• Business teams have clear guidance on compliance expectations and required documentation.
• Backlog remediation activities and ongoing compliance intake are supported without creating additional compliance delays or rework.

What you'll bring

• 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 with the 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, Word, Excel, PowerPoint, Outlook, and Teams.
• Ability to use Excel to organize information, review data, track open items, and support reporting needs. Candidates should have intermediate Excel Skills (XLookup, Sorting & Filtering Data, Creating Pivot Tabels).
• Clear written and verbal communication skills with the ability to work across multiple teams.
• Strong organization skills and the 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 the ability to escalate risks or gaps appropriately.

Applicant Notices & Disclaimers

• For information on benefits, equal opportunity employment, and location-specific applicant notices, click here