Quality Auditor – cGMP & Compliance Specialist

Sharp Clinical Services; Allentown (Lehigh County); On-site; USD 65,000 - 90,000; Full time

Job summary

Sharp Clinical Services in Allentown seeks a Quality Auditor to manage customer audits, supplier audits, and internal cGMP compliance audits across our US facilities. The role includes supporting regulatory inspections and coordinating CAPA processes with management to ensure ongoing compliance and risk mitigation.

Qualified candidates will have at least one year of cGMP auditing experience, strong regulatory knowledge (FDA cGMPs, ISO 13485), and excellent communication and organizational

Qualifications

• One year of experience conducting cGMP compliance audits.
• Knowledge of FDA cGMPs regulation (21 CFR 210/211, 820, Part 4).
• Knowledge of ISO 13485 and related guidance.
• ICH08/09/10 knowledge desirable; DEA regulations and ISO 9001/ISO 15378 desired.
• Strong written and oral communication; good organization and planning abilities.

Responsibilities

• Host customer audits and respond to audit observations.
• Support supplier audit program, including supplier qualifications and audit reports.
• Perform internal audits and document findings; track CAPA and effectiveness checks.
• Coordinate CAPA processes across audits and inspections; participate in regulatory inspections.
• Identify continuous improvement areas and stay current with FDA trends and cGMP guidance.

Skills

cGMP auditing

FDA cGMP knowledge

ISO 13485 knowledge

Regulatory inspections

Written and oral communication

Organizational skills

Travel readiness

Job description

Sharp Clinical Services in Allentown seeks a Quality Auditor to manage customer audits, supplier audits, and internal cGMP compliance audits across our US facilities. The role includes supporting regulatory inspections and coordinating CAPA processes with management to ensure ongoing compliance and risk mitigation.

Qualified candidates will have at least one year of cGMP auditing experience, strong regulatory knowledge (FDA cGMPs, ISO 13485), and excellent communication and organizational