Quality Compliance Associate

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