Senior Pharmaceutical Quality Auditor (GMP / Medical Device)

United States·AnaheimAudit - 1-2 Daysenior

OtherQuality Auditor

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Overview

For more than 30 years, SQA Services has been a leader in providing managed supplier quality services — including audits, assessments, corrective actions, inspections, remediation, and engineering support — to manufacturers across regulated industries.

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OtherQuality Auditor

For more than 30 years, SQA Services has been a leader in providing managed supplier quality services — including audits, assessments, corrective actions, inspections, remediation, and engineering support — to manufacturers across regulated industries. We deploy experienced auditors and quality professionals across the United States and in over 90 countries to support client and supplier sites on demand.

SQA Services is seeking a Senior Pharmaceutical Quality Auditor to support ongoing supplier audits throughout Southern California and surrounding regions.

This role requires a highly experienced auditor with a strong background in pharmaceutical GMP auditing, including experience leading external supplier audits independently. The ideal candidate will be located near a major transportation hub in Southern California and willing to travel to support a minimum of 2 audits per month.

Lead supplier audits in pharmaceutical and regulated manufacturing environments

Conduct audits to 21 CFR 210/211, EU GMP Vol. 4, Canada GMP, and applicable quality standards

Assess supplier quality systems, manufacturing controls, documentation, and compliance practices

Support audits involving medical device quality systems (ISO 13485 / 21 CFR 820)

Prepare detailed audit reports and communicate findings to stakeholders

Represent SQA professionally at supplier sites and client engagements

Support corrective action review and supplier follow-up activities as needed

15+ years of experience in Quality within pharmaceutical or regulated industries

Minimum 5+ years performing audits as a lead auditor

Experience conducting external supplier audits independently

Strong experience with 21 CFR 210/211, EU GMP Vol. 4, and/or Canada GMP

Familiarity with ISO 13485 and/or 21 CFR 820