Remote Senior Quality Associate, Biotech Cell Therapy

Aurion Biotech Inc.; Seattle, Boston (WA, MA); Hybrid; USD 92,000 - 102,000; Full time

Job summary

Aurion Biotech Inc. is seeking a Senior Quality Associate for a fully remote role based in the United States (WA preferred).

The successful candidate will support the implementation and maintenance of the Quality Management System and collaborate with CDMOs and CTLs to ensure compliant cell-therapy products. Requirements include a Bachelor’s in biology/chemistry and 4+ years of cGMP QA experience, with strong documentation, regulatory knowledge, and MS Office skills.

Qualifications

• Bachelor’s degree in Biology, Chemistry or related field.
• 4+ years of full-time cGMP Quality Assurance experience.
• Experience with eQMS systems (ACE, TrackWise).
• Strong documentation and record-keeping skills.

Responsibilities

• Author and review SOPs.
• Provide Quality Onboarding training.
• Review manufacturing records for product disposition.
• Support computer system validation activities.
• Support quality performance/continuous improvement activities.
• Assist in compiling metrics for Quality Management Review.

Skills

cGMP

Quality Assurance

Documentation

MS Office

Cross-functional communication

Education

Bachelor’s degree in Biology or Chemistry

Tools

ACE

TrackWise

Job description

Aurion Biotech Inc. is seeking a Senior Quality Associate for a fully remote role based in the United States (WA preferred).

The successful candidate will support the implementation and maintenance of the Quality Management System and collaborate with CDMOs and CTLs to ensure compliant cell-therapy products. Requirements include a Bachelor’s in biology/chemistry and 4+ years of cGMP QA experience, with strong documentation, regulatory knowledge, and MS Office skills.