Quality Associate

Aurion Biotech; United States; Remote; USD 56,000 - 78,000; Full time

Job summary

An innovative clinical-stage biotech company is seeking a Quality Associate to join their dynamic team. This role offers a unique opportunity to contribute to the advancement of regenerative therapies for vision restoration. As a Quality Associate, you will play a critical role in supporting Quality Management Systems and ensuring compliance with industry standards. Your responsibilities will include reviewing batch records, authoring SOPs, and participating in continuous improvement initiatives. With a commitment to employee growth and well-being, this forward-thinking organization provides a collaborative environment where your contributions can make a real difference in patients' lives.

Benefits

Catered lunches

Team events

Community projects

Competitive compensation

Robust benefits

Qualifications

• 1+ year of cGMP Quality Assurance experience preferred.
• Bachelor’s degree in a relevant scientific field is ideal.

Responsibilities

• Review executed batch records and support Drug Product disposition activities.
• Author and review Standard Operating Procedures (SOPs).
• Assist in compiling metrics for Quality Management Review.

Skills

eQMS (e.g., ACE, TrackWise)

Computer system validation

Batch disposition principles

Record keeping and documentation

MS Office proficiency

Adaptability to changing environments

Teamwork and independence

Education

Bachelor’s degree in Biology

Bachelor’s degree in Chemistry

Relevant scientific discipline

Tools

eQMS systems

Quality Management Systems

Job description

Join to apply for the Quality Associate role at Aurion Biotech.

This range is provided by Aurion Biotech. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$56,000.00/yr - $78,000.00/yr

Job Title and Location

JOB TITLE: Quality Associate

LOCATION: Remote candidates based in IN, MA, NC, NH, NM, NY, PA, SC, SD, TX, or WA will be considered.

Salary Range

$56,000 to $78,000, with a midpoint of $71,000. Hiring at or around the midpoint is ideal.

About the Position

This is an exciting opportunity to join a growing team at the forefront of cell therapy and cornea care innovation. As a Quality Associate, you will support the implementation, maintenance, and improvement of Quality Management Systems and assist in Drug Product disposition activities.

Key Responsibilities

• Review executed batch records
• Support Drug Product disposition activities
• Author and review Standard Operating Procedures (SOPs)
• Support computer system validation activities
• Support Quality performance/continuous improvement activities
• Assist in compiling metrics for Quality Management Review
• Perform other duties as assigned

Qualifications & Education

• Bachelor’s degree in Biology, Chemistry, or a relevant scientific discipline (preferred)
• Preferred one (1) year of full-time cGMP Quality Assurance experience

Required Skills, Knowledge, and Abilities

• Experience with eQMS (e.g., ACE, TrackWise)
• Knowledge of computer system validation
• Understanding of industry practices and standards in an FDA-regulated biotech company
• Good understanding of batch disposition principles
• Excellent record keeping and documentation skills
• Proficiency in MS Office
• Ability to adapt quickly to changing environments, ensuring cGMP and regulatory compliance
• Ability to work independently and in teams

About Aurion Biotech

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company focused on regenerative therapies for vision restoration. Our first candidate addresses corneal edema due to endothelial dysfunction and has received regulatory approval in Japan. We are rapidly growing and value diversity, innovation, and resilience. Backed by Alcon, we are preparing for clinical trials in the U.S. and aim to make a difference in patients' lives.

Life at Aurion Biotech

We invest in our employees’ well-being and growth through robust benefits, competitive compensation, and fun perks such as catered lunches, team events, and community projects.

Additional Information

• Seniority level: Associate
• Employment type: Full-time
• Job function: Quality Assurance
• Industry: Biotechnology