Quality Compliance Associate Large Pharmaceutical Company is searching for a Quality Compliance Associate to join the Quality Compliance team in Irvine, CA!
In this role, you will:
Co-lead internal audits for the site's compliance to GMP regulations, collaborate with departmental stakeholders to oversee that needed actions are addressed in a timely fashion.
Facilitate the site's routine gap assessment process between new/updated corporate standards and site procedures.
Drive timely input from departmental stakeholders for conducting gap assessments and completing subsequent CAPAs to close identified gaps.
Inform senior leadership and corporate leaders of critical compliance issues through the escalation procedure; orchestrate activities related to field alerts, market action decisions, and related corrective activities.
Participate and take active role in regulatory inspections and communications.
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 Supplier Quality Management and collaborate with stakeholders working to qualify new suppliers, new materials, and GMP vendors for the site.
Conduct periodic reviews of established suppliers, ensure appropriate updates per management of change process.
Establish and renew Quality Agreements with suppliers, monitor supplier audit results/responses.
Write and peer-review investigations, risk assessments, and root cause analysis related to product post-market surveillance and complaints.
Participate in monthly and quarterly routines for the site's compliance, including the site's quality council, annual product reviews and related sub-reports, and various trending reports.
Qualifications:
BA degree in related science, engineering or similar required 5 years QA or Compliance experience in a highly regulated environment required.5 years of technical writing experience required 2 years working in Sterile / Aseptic operating environment is required 2 years of experience working on GMP compliance, data integrity, auditing, investigations, CAPAs, and change management required
