Quality Engineer III

Quality Engineer III supports quality assurance for clinical and commercial manufacturing programs at a regulated pharmaceutical environment. The role involves investigating quality events, ensuring GMP compliance, and driving continuous improvement across cross-functional teams.

Responsibilities

• Support quality assurance activities for clinical and commercial manufacturing programs
• Review and approve GMP documentation including batch records, deviations, and CAPA submissions
• Lead quality investigations, perform root cause analyses, and implement corrective actions
• Evaluate quality data and metrics to identify trends and recommend process improvements
• Participate in internal audits, customer audits, and regulatory inspections

Requirements

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or related scientific discipline
• Advanced degree with 3+ years QA experience, or bachelor's with 5+ years in regulated manufacturing
• Demonstrated experience with GMP quality systems and regulatory compliance
• Working knowledge of FDA, EMA, ICH, GMP regulations and requirements
• Strong analytical skills, root cause problem-solving, and attention to detail
• ASQ CQE, CQA, or equivalent quality certification (preferred)
• Experience with biologics manufacturing or process validation (preferred)