Senior Quality Assurance Lead - Remote Cell Therapy

Aurion Biotech; Washington; Híbrido; USD 92.000 - 102.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) matching

Paid time off

Remote work setup support

Descripción de la vacante

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

Formación

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

Responsabilidades

• 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.

Conocimientos

Quality Assurance

Documentation

MS Office

Communication

CDMO experience

Educación

Bachelor’s degree Biology or Chemistry

Herramientas

eQMS

Descripción del empleo

Fully Remote • US Remote - WA, MA, NC, NJ, NH, NM, NY, PA, SC, SD, TX, KY, MS, IN applicants only

Description

JOB TITLE: Senior Quality Associate

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

SALARY RANGE: $92,000 to $102,000

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 Senior Quality Associate, you will play a critical role in accomplishing this mission and in staging Aurion Biotech novel cell therapy treatment for successful launch in the United States.

The primary purpose of the Senior Quality Associate is to support the implementation, maintenance, and improvement of the Quality Management System and support Contract Development and Manufacturing Organization (CDMO) and Contract Testing Lab (CTL) management.

KEY 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
• 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.

Requirements

QUALIFICATIONS AND 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 Biology, Chemistry or other relevant scientific discipline preferred.
• 4+ years of full-time cGMP Quality Assurance experience.

REQUIRED SKILLS AND ABILITIES

• Travel required up to 35%.
• Experience with eQMS (e.g., ACE, TrackWise)
• Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company
• Excellent record keeping and documentation skills
• Strong communication skills, both verbal and written, with the ability to concisely present information in cross-functional settings
• Experience working with CDMOs prefererd
• 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.