Quality Assurance Associate II/III

Role Summary

Quality Assurance Associate II/III responsible for supporting cGMP-compliant clinical production activities, including batch record review, deviation investigations, label issuance, and management of controlled documentation within GLP/GCP/GMP systems.

Responsibilities

• Lead batch record review and disposition for clinical product manufacturing, including label issuance, product packaging, and shipping activities
• Own deviation investigations and CAPA processes, ensuring timely resolution and compliance; author and approve associated reports
• Drive change control evaluations and oversee implementation of approved changes
• Manage controlled documentation within the GxP system (GLP/GCP/GMP), including issuing, tracking, distributing, and archiving records using electronic document management systems
• Develop and enhance quality management systems, including training programs, SOPs, and standards; provide guidance and mentorship to junior team members
• Coordinate and maintain controlled records (batch/test records, logbooks, validation documents, labels, reports, forms) for audits, training, equipment calibration, and preventive maintenance
• Author and approve policies, standards, procedures, and work instructions to ensure compliance and operational excellence
• Lead supplier quality activities, including qualification, monitoring, and performance reviews
• Oversee inventory database accuracy, including lot number tracking and timely updates; approve release of incoming materials
• Represent QA during regulatory inspections and internal audits, preparing and presenting relevant documentation
• Contribute to regulatory submission activities and ensure readiness for management and material review boards
• Champion continuous improvement initiatives across QA processes and systems

Qualifications

• Bachelor‚Äôs degree in a scientific discipline (Life Sciences, Engineering, or related field)
• 3‚Äì5 years of progressive QA experience in a cGMP-regulated environment
• Demonstrated expertise in batch record disposition, deviation/CAPA management, and change control oversight
• Strong knowledge of FDA regulations (21 CFR Parts 210/211), ICH guidelines, and quality systems
• Ability to author and approve SOPs and quality documentation; experience with electronic document management systems
• Excellent communication, problem-solving, and decision-making skills
• Proven ability to work independently, lead initiatives, and mentor junior staff