Quality Specialist III

Quality Specialist III – Audits & Inspections

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

About the Opportunity

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.

What You’ll Do

Audits & Inspections

• 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.

Inspection Readiness & Compliance

• 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.

Quality Metrics & Governance

• 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.

Deviation & CAPA Management

• 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.

Documentation & Communication

• 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.

What We’re Looking For

• 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.

Preferred Experience

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

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

• Experience coordinating mock inspections and preparing subject matter experts.

• Experience with quality metrics, trending, risk identification, and continuous improvement.

• Experience with electronic Quality Management Systems such as TrackWise, Veeva Vault, or Documentum .

Knowledge & Skills

• Strong working knowledge of applicable regulations and standards, including:

• 21 CFR Parts 210/211 – Current Good Manufacturing Practice

• 21 CFR Part 600 – Biologics

• 21 CFR Part 820 / QMSR – Quality Management System requirements

• ISO 13485

• ISO 9001

• ICH Q9 and Q10

• Excellent written and verbal communication skills.

• Ability to communicate complex quality concepts to stakeholders at all levels.

• Strong problem-solving and issue-resolution skills.

• Excellent organization and time-management abilities.

• Strong attention to detail with an eye for identifying compliance and process-improvement opportunities.

• Ability to build relationships and work effectively across functions and organizational levels.

Work Environment

This position is fully onsite in Greenville, NC , Monday through Friday during standard business hours. Remote work is not available.

Why Consider This Opportunity?

This is an opportunity to take on a meaningful role within a highly regulated quality organization, supporting audit and inspection readiness while partnering across functions to strengthen compliance, manage quality commitments, and drive continuous improvement.

Contract-to-hire structure: The initial assignment is expected to run for one year, with the potential for transition to a permanent position based on business needs and performance.

Pay Details: $40.00 to $45.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act

• Los Angeles City Fair Chance Ordinance

• Los Angeles County Fair Chance Ordinance for Employers

• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.