Quality Specialist III

Location: Greenville, NC

Pay: Up to $45/hour

Employment Type: 1-Year Contract-to-Hire

Schedule: Monday–Friday, Standard Business Hours

Work Arrangement: 100% Onsite | No Remote Work

We are seeking an experienced Quality Specialist III – Audits & Inspections to support audit execution, regulatory inspection readiness, and quality compliance within a highly regulated pharmaceutical and medical device environment.

This is a hands‑on quality role for someone who understands what it takes to prepare an organization for audits and inspections, coordinate cross‑functional teams, track commitments, and ensure quality actions are completed effectively and on time.

The ideal candidate will bring strong experience in Quality Assurance, audits and inspections, deviation and CAPA management, regulatory compliance, and quality systems
, along with the communication skills needed to work effectively with stakeholders across the organization.

• Support the planning, scheduling, coordination, and execution of internal and external client audits.

• Support mock inspections and regulatory inspections involving health authorities such as the FDA, EMA, ANVISA, and MHRA .

• Coordinate cross‑functional audit and inspection activities.

• Help prepare subject matter experts for auditor and inspector interactions.

• Track audit findings, commitments, responses, and follow‑up activities through completion.

• Maintain ongoing inspection readiness by ensuring required documentation and records are complete, accurate, and readily accessible.

• Support compliance with applicable pharmaceutical and medical device regulations and quality standards.

• Identify potential compliance gaps and partner with functional teams to address risks proactively.

• Track, trend, and analyze audit, inspection, deviation, and quality data to identify systemic risks and recurring issues.

• Support audit and inspection KPIs and quality metrics reporting.

• Provide meaningful quality insights to leadership and support continuous improvement initiatives.

• Monitor deviations, audit‑related CAPAs, and health authority commitments.

• Ensure corrective and preventive actions are completed within established timelines.

• Support the development and completion of appropriate CAPA effectiveness checks.

• Evaluate whether corrective actions effectively address root causes and help prevent recurrence.

• Maintain accurate audit, inspection, and quality records in accordance with applicable procedures and record‑retention requirements.

• Ensure critical documentation is organized and readily available for audits and inspections.

• Communicate quality expectations, findings, timelines, and action items clearly across functions.

• Build strong working relationships with Quality, Operations, and other cross‑functional teams.

• Bachelor’s degree in a scientific, engineering, healthcare, or related field.

• 8+ years of experience in Quality within the pharmaceutical, biotechnology, medical device, or related regulated healthcare industry.

• Experience with areas such as:

• Quality Assurance

• Internal and external audits

• Regulatory inspections

• Deviation management

• CAPA management

• Quality systems

• Regulated manufacturing operations

• Hands‑on experience supporting audit and inspection readiness activities.

• Strong understanding of applicable pharmaceutical and/or medical device quality requirements.

• Experience supporting FDA, EMA, ANVISA, MHRA , or other health authority inspections.

• Pharmaceutical, biologics, biotechnology, medical device, or other highly regulated manufacturing…