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.