Quality Associate

Aurion Biotech, Inc.; North Carolina; Remote; USD 71,000; Full time

Job summary

An innovative clinical-stage biotech company is seeking a Quality Associate to join their passionate team. This role is pivotal in supporting the Quality Management Systems and ensuring compliance with regulatory standards in cell therapy and cornea care. The ideal candidate will have a strong scientific background, excellent documentation skills, and experience in FDA-regulated environments. You will contribute to impactful projects that aim to restore vision to millions, making this an exciting opportunity for those looking to make a difference in the biotech field. Join a collaborative and dynamic team dedicated to transforming patient care through groundbreaking therapies.

Benefits

Full health insurance

401(k) matching

Generous PTO

Paid parking

Subsidized commuter passes

In-office catered lunches

Team events

Community projects

Qualifications

• Bachelor’s degree in a relevant scientific discipline preferred.
• One year of full-time cGMP Quality Assurance experience preferred.

Responsibilities

• Review executed batch records and support Drug Product disposition activities.
• Author and review Standard Operating Procedures (SOPs) and support validation activities.

Skills

eQMS experience

computer system validation knowledge

FDA-regulated industry knowledge

batch disposition principles understanding

record-keeping and documentation skills

MS Office proficiency

adaptability and flexibility

Education

Bachelor’s degree in Biology

Bachelor’s degree in Chemistry

Tools

ACE

TrackWise

Job description

Fully Remote • US Remote - WA or MA Preferred - WA, NM, SD, TX, IN, SC, NC, PA, NY, NH or MA applicants only

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

SALARY RANGE: $56,000 to $78,000. The midpoint of the range is $71,000. The ideal candidate would be hired at or around the midpoint.

ABOUT THE POSITION

This is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy and cornea care innovation. As a Quality Associate, you will play a critical role in accomplishing this mission and in staging Aurion Biotech's novel cell therapy treatment for successful launch in the United States. The primary purpose of the Quality Associate is to support the implementation, maintenance, and improvement of the 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
• Other duties as assigned.

ABOUT AURION BIOTECH

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:

• Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
• Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate.
• Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments.

Aurion Biotech has a lot to accomplish in the next few years and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

QUALIFICATIONS & EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s degree in Biology, Chemistry, or other 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
• Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company
• Good understanding of batch disposition principles
• Excellent record-keeping and documentation skills
• Proficient use of MS Office products
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and Regulatory requirements are met
• Ability to work effectively both independently and with other team members