Senior Quality Assurance Lead - Remote Cell Therapy

Aurion Biotech; Northern (KY); Hybrid; USD 92,000 - 102,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Remote work setup support

Job summary

Aurion Biotech seeks a Senior Quality Associate to support the Quality Management System and CDMO/CTL partnerships in the United States. This fully remote role aligns with candidates in specified states and offers comprehensive responsibilities across SOP authoring, onboarding, records review, and quality metrics support.

Ideal candidates will have cGMP QA experience, strong documentation skills, and the ability to collaborate across cross-functional teams in a fast-paced cell therapy

Qualifications

• Bachelor’s degree Biology, Chemistry or other relevant scientific discipline preferred.
• 4+ years of full-time cGMP Quality Assurance experience.

Responsibilities

• Author and review Standard Operating Procedures (SOPs).
• Provide Quality Onboarding training.
• Review executed manufacturing records in support of product disposition.
• Support computer system validation activities.
• Support quality performance/continuous improvement activities.
• Assist in compiling metrics for Quality Management Review.

Skills

Quality Assurance

Documentation

MS Office

Communication

CDMO experience

Education

Bachelor’s degree Biology or Chemistry

Tools

eQMS

Job description

Aurion Biotech seeks a Senior Quality Associate to support the Quality Management System and CDMO/CTL partnerships in the United States. This fully remote role aligns with candidates in specified states and offers comprehensive responsibilities across SOP authoring, onboarding, records review, and quality metrics support.

Ideal candidates will have cGMP QA experience, strong documentation skills, and the ability to collaborate across cross-functional teams in a fast-paced cell therapy