Quality Assurance Auditor

Quality Assurance AuditorPharmaceutical client in Irvine, CA is searching for a Quality Assurance Auditor to join the Quality Compliance team in Irvine, CA! In this role, you will:Lead internal audits for the site's compliance to GMP regulations, collaborate with departmental stakeholders to oversee that audits are executed in a timely fashion.Write internal audit reports and drive departmental stakeholders for timely responses to internal audit results as well as completing subsequent CAPAs to close identified gaps or process improvements.Participate and take active role in regulatory inspections and customer audits.Work with subject matter experts to keep the site inspection-ready, organizing resources and materials, and provide input on correspondences with the regulatory authorities.Support the Supplier Quality Management program and collaborate with stakeholders working to qualify new suppliers, new materials, and GMP vendors for the site.Lead the periodic review program of established suppliers, ensure appropriate updates per management of change process.Establish and renew Quality Agreements with suppliers, monitor supplier audit results/responses, and on occasion, participate in audits of suppliers.Write and peer-review investigations, risk assessments, and root cause analysis related to potential supplier quality events.Notify senior leadership and corporate leaders of critical compliance issues through the escalation procedure; orchestrate activities related to global notifications for critical supplier findings, field alerts, market action decisions, and related corrective activities.Participate in monthly and quarterly routines for the site's compliance, including the site's quality council, quality metrics reporting, and various trending reports.Occasional travel, less than 10%, to regional Supplier Quality Management audits.Qualifications:BA degree in related science, engineering or similar required6 years QA or Compliance experience in an FDA regulated environment/industry required4 years working in Sterile / Aseptic operating environment is required6 years of technical writing experience required4 years of experience as SME on GMP compliance, data integrity, auditing, investigations, CAPAs, and change management required