The QA Associate will support quality operations activities for the manufacture of cellular therapy products. This highly dynamic role will contribute to the advancement of KSQ products by ensuring quality oversight at contract manufacturing facilities and contributing to the Culture of Quality by facilitating the evolvement of the internal Quality Management System.

• Ensure the safety and quality of manufactured product through the review and approval of executed batch records
• Provide quality oversight of external quality records including: deviations, change controls, investigations…etc)
• Interface with external vendors to provide risk-based phase appropriate oversight
• Support the Vendor management program including: audits, development and application of vendor scorecards, and assessment of external change notifications
• Review and approve internal quality system records including: deviations, CAPAs, and change controls
• Support administration of the internal electronic Quality Management System
• Administer and evolve the training program to ensure a state of GxP compliance
• Generate and gather metrics to support the development of internal Quality Management Review

WHAT YOU’LL BRING TO THIS ROLE

• BS/BA in a science/engineering field and a minimum of 3 years working in Quality, with experience in cell therapy (or applicable) environment preferred.
• Demonstrated ability to interact with cross-functional to drive a Quality Culture and continuous improvement
• Experience with Quality oversight of external vendors
• Excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines
• Experience in maintaining, and optimizing a Quality Management System
• Specific skills include, but are not limited to Deviation/CAPA Management, Change Control, Vendor Management

KSQ is deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.

KSQ is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.