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Senior Pharmaceutical Quality Auditor (GMP / Medical Device) en Sqaservices

Sqaservices · Anaheim, Estados Unidos De América · On-site

$312,000.00  -  $364,000.00

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Description

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.

Key Responsibilities

  • 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

    • Required Qualifications

  • 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
  • Strong written and verbal communication skills
  • Willingness to travel throughout Southern California and surrounding regions
  • Availability to support a minimum of 2 audits per month

    • Preferred Qualifications

  • Experience with ISO 17025 (Laboratories)
  • Experience auditing packaging (ISO 15378), warehousing/distribution, excipients, or APIs
  • Additional experience with Food or Animal Health standards (21 CFR 110, 111, 120, or 507)
  • Located near Los Angeles or another major Southern California transportation hub

    • Additional Information

    Note:
     
    SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications, and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status.​
     
    This position requires access to ITAR-controlled technical data and/or defense articles. As such, the candidate must be a U.S. citizen or U.S. lawful permanent resident (green card holder) to comply with the International Traffic in Arms Regulations (ITAR). Applicants who do not meet these criteria will not be considered for this role.
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