Quality Investigator (Pharmaceutical)

TL;DR

Quality Investigator (Pharmaceutical): Leading investigations into non-conformances, deviations, and quality events within a pharmaceutical manufacturing environment with an accent on root cause analysis and CAPA implementation. Focus on ensuring strict regulatory compliance, preparing technical investigation reports, and driving continuous process improvement.

Location: Onsite in Irvine, California, United States

Salary: $71,169 - $89,000

Company

hirify.global is a global leader in infusion therapy and pain management, providing innovative medical products and services to the healthcare industry worldwide.

What you will do

• Lead investigations of quality events, non-conformances, deviations, and product complaints.
• Conduct root cause analyses and recommend corrective and preventive actions (CAPAs).
• Prepare detailed investigation reports and present findings to Quality Management.
• Manage quality records and track corrective actions through to closure.
• Review quality documentation to support product release and regulatory compliance requirements.
• Support internal and external audits and collaborate cross-functionally to resolve process issues.

Requirements

• Bachelor's degree.
• 2+ years of experience in Quality, Manufacturing, Engineering, or a regulated environment.
• Knowledge of GMP, quality systems, investigations, and CAPA processes.
• Strong analytical, problem-solving, and technical writing skills.
• Ability to work onsite in Irvine, California.

Nice to have

• Experience in pharmaceutical, medical device, biotech, or other regulated industries.

Culture & Benefits

• Comprehensive healthcare package.
• 401(k) retirement plan.
• Tuition reimbursement.
• Environment focused on "Sharing Expertise" for continuous improvement of healthcare products.