Senior Specialist, QA Operations

Responsibilities

• Review executed batch records and supporting documentation to ensure accuracy, completeness, and compliance with applicable requirements.
• Support batch disposition and product release activities while maintaining adherence to established timelines.
• Consistently meet production release schedules and quality deliverables.
• Proactively identify, investigate, and escalate quality and compliance issues to Quality Management.
• Provide quality oversight and guidance regarding documentation discrepancies, deviations, and compliance-related matters.
• Maintain and update the vendor change notification tracking system and support the monitoring of key quality and operational performance metrics.
• Partner with cross-functional teams to facilitate the timely assessment, implementation, and closure of vendor change notifications.
• Support quality system processes, including deviations, change controls, CAPAs, and vendor change management activities.
• Ensure compliance with cGMP regulations, ICH guidelines, and company SOPs and quality standards.
• Author, review, revise, and maintain SOPs and other controlled documents to standardize and improve business processes.
• Contribute to continuous improvement initiatives and enhancements to the Quality Management System (QMS).
• Support inspection readiness activities, internal and external audits, and perform additional responsibilities as assigned.

Requirements

• Bachelor’s degree in a life sciences discipline (e.g., biology, immunology, biochemistry) or equivalent experience
• Minimum of 6 years of experience in Quality Assurance or a related role within biotech, pharmaceutical, or cell/gene therapy industries
• Strong ability to manage multiple priorities in a fast-paced environment with keen attention to detail
• Highly organized, self-motivated, and capable of working independently while following through on responsibilities
• Excellent written and verbal communication skills, with the ability to collaborate effectively across all organizational levels
• Ability to work in a matrix environment and build strong relationships by being transparent, reliable, and delivering on commitments.