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Form of work Job Description: Quality Assurance Auditor
Pharmaceutical 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:
Pharmaceutical 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.
- BA degree in related science, engineering or similar required
- 6 years QA or Compliance experience in an FDA regulated environment/industry required
- 4 years working in Sterile / Aseptic operating environment is required
- 6 years of technical writing experience required
- 4 years of experience as SME on GMP compliance, data integrity, auditing, investigations, CAPAs, and change management required
