Quality Assurance Auditor
Aequor JD ·www.aequor.com
Apply direct 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
Frequently asked questions
Who is hiring for the Quality Assurance Auditor role?
Aequor JD is hiring for the Quality Assurance Auditor position, a Shazamme client. Apply directly on the employer's career site.
Where is the Quality Assurance Auditor job located?
The Quality Assurance Auditor role with Aequor JD is based in Irvine, CA, US.
Is the Quality Assurance Auditor role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Quality Assurance Auditor role?
The Quality Assurance Auditor position is aimed at mid-level candidates.
How do I apply for the Quality Assurance Auditor role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.