Quality Specialist III

Our client, a leading pharmaceutical and medical device organization is seeking a Quality Specialist to join their team. As a Quality Specialist III, you will be part of the Quality organization supporting Audits & Inspections. The ideal candidate will have strong attention to detail, the ability to collaborate cross-functionally, and a commitment to continuous improvement—skills that will align successfully in the organization.

Quality Specialist

Greenville, NC

$45

• Execute and maintain the Internal Audit, Client audit, and Regulatory inspection programs to support quality compliance.
• Support external audit preparation by coordinating scheduling, hosting, and timely responses to client audit findings.
• Drive inspection readiness by supporting mock inspections and actual regulatory inspections with health authority agencies such as FDA, EMA, ANVISA, and MHRA.
• Support governance by tracking, trending, and analyzing audit/inspection data and quality issues to identify systemic risks and drive continuous improvement.
• Monitor deviations and CAPAs, including health authority commitments, ensuring responses and actions are completed and submitted on time; perform effectiveness checks for assigned audit CAPAs.

• Bachelor's degree in a scientific, engineering, or health-related field.
• At least 5 years of experience working within the pharmaceutical or medical device industry.
• At least 8 years of experience working in quality within the pharmaceutical or medical device industry in deviation management, pharmaceutical operations, quality assurance, or relevant business areas.
• Strong working knowledge of 21 CFR Part 210/211 current Good Manufacturing Practice, 21 CFR Part 600 Biologics, 21 CFR Part 820 QMSR, ISO 13485, ISO 9001, and ICH Q9 and Q10.
• Proficiency in electronic quality management systems such as Documentum, Veeva Vault, and Track Wise, along with strong communication, organizational, and problem-solving skills.

• Opportunity to strengthen inspection readiness and support regulatory success through structured audits and mock inspections.
• Clear impact on quality outcomes by monitoring deviations, CAPAs, and health authority commitments.
• Visibility with senior leadership through KPI reporting and ongoing program performance updates.
• Hands-on collaboration across teams to coach subject matter experts and coordinate cross-functional audit activities.
• Professional growth through continuous improvement focused on systemic risk identification and effectiveness verification.

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay