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Sharp Services · 1 day ago

Quality Assurance Auditor

Allentown

Full-time

Onsite

Entry Level

1+ years exp

Sharp Services is seeking a Quality Assurance Auditor to oversee customer and supplier audits, as well as internal cGMP compliance audits. This role is crucial for maintaining compliance and managing the audit process across various facilities, ensuring effective corrective actions and continuous improvement.

Health CareLife Science

Responsibilities

Host customer audits

Write responses to customer audit observations

Support the supplier audit program, including auditing suppliers and writing of supplier qualifications, routine and for cause audit reports

Support site specific internal audit program, including performing and documenting internal audits

Review and evaluate the appropriateness of supplier and internal audit responses to ensure effective CAPAs and effectiveness checks are in place

Participate in regulatory agency inspections

Coordinate the Root Cause and Corrective Action / Preventative Action (CAPA) process as it relates to all audits and inspections

Identify areas for continuous improvement as part of audit process

Remain current with FDA inspectional trends and current industry standards for cGMP compliance

Follow Sharp SOPs governing internal and supplier audit programs. Follow ISO 13485, principles of cGMPs and industry guidance documents

Assist in appropriate problem-solving initiatives to address customer or regulatory cGMP issues as requested by management

Other duties may be assigned as appropriate

Qualification

CGMP compliance auditsFDA cGMPs regulationISO 13485ICH guidelinesDEA regulationsISO 9001ISO 15378Planning skillsWritten communicationOral communicationOrganization skills