Quality Assurance & Compliance Audit Lead

Sharp Services, LLC; Allentown (Lehigh County); On-site; USD 95,000 - 125,000; Full time

Job summary

Sharp Services, LLC is seeking a Senior Quality Audit Specialist in Allentown to lead and manage customer, internal, and supplier audits. The role requires deep knowledge of FDA regulations (FDA 21 CFR 210, 211, 820 and 821) and cGMP quality systems.

You will coordinate audits, develop corrective actions, monitor quality metrics, and mentor teams while supporting site process improvements and regulatory readiness.

Qualifications

• Bachelor's/Associates degree in science or technical field preferred.
• Minimum 7 years of experience in a cGMP environment.
• Advanced knowledge of GMPs, GDPs, GLPs and QA/QC.

Responsibilities

• Coordinate and execute customer audits, including prep, hosting, and closure.
• Monitor trends and metrics of quality events and CAPAs.
• Back-up Management Representative for inspections.
• Lead development and submission of audit responses and CAPAs.
• Drive quality improvement projects and cross-functional initiatives.
• Plan and manage internal and supplier audits and reporting.

Skills

Audit management

Regulatory knowledge

Quality systems

Cross-functional collaboration

Problem solving

Communication

Education

Bachelor's degree in science/technical field

Tools

Microsoft Office

Job description

Sharp Services, LLC is seeking a Senior Quality Audit Specialist in Allentown to lead and manage customer, internal, and supplier audits. The role requires deep knowledge of FDA regulations (FDA 21 CFR 210, 211, 820 and 821) and cGMP quality systems.

You will coordinate audits, develop corrective actions, monitor quality metrics, and mentor teams while supporting site process improvements and regulatory readiness.