Document Control Specialist, Quality Assurance, Quality Systems

Join us as a Document Control Specialist I!

Join Abeona Therapeutics as a Document Control Specialist I and be a part of a mission-driven organization devoted to putting patients first. In this role, you will play a crucial part in ensuring that our cutting-edge health care solutions meet the highest quality standards. Collaborate with talented individuals dedicated to transforming lives through innovative therapies.

Work both onsite and remotely, Monday to Friday (some late or weekend work may be required), and contribute to impactful products that change people's lives. With a competitive salary of $62,000 to $65,000 per year, plus an annual discretionary bonus, this early-career position not only offers financial rewards, but also the opportunity to build your career in a supportive, collaborative, and values-focused environment.

You will have options to participate in a comprehensive benefits program that includes options for Medical insurance to meet various individual/family needs, company covered basic Dental and Vision insurance (with additional coverage options), HSA and FSA options, a Lifestyle Spending Account, 401k options (with a company match program), and up to 160 hours of Paid Time Off per calendar year.

Oh, and snacks! We have healthy snacks and beverages, as well as a few good, old-fashioned sweets, so that you can keep those energy levels up throughout the day.

Abeona Therapeutics Inc.:
Who We Are

Our Values:
Patient First | Innovation | Integrity | Determination | Trust

Join us in making cure the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.

Your day-to-day as a Document Control Specialist I

As a Document Control Specialist I at Abeona Therapeutics, your day-to-day activities will focus on routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position is responsible for document review which includes, but is not limited to: editing, formatting, and proofreading prior to SME approval in the Quality Management System.

The Document Control Specialist will support all document review and retention/archiving for the site.

The position has flexibility in conducting some work activities remotely (based on site needs) while also having work that requires him/her to be at the office on a regular basis. All days working remotely require manager approval.

Your expertise will directly impact the quality and reliability of our therapeutic solutions, all while upholding our commitment to putting patients first. This position enables you to contribute meaningfully to the advancement of gene-based therapy solutions in a compliance-focused environment.

Schedule

The usual working hours for this role are first shift, Monday to Friday (some late or weekend work may be required and start and end times may vary based on business needs)

Does this sound like you?

You may be a great fit for this role if you bring a strong foundation in quality and compliance, enjoy working with precision, and take pride in keeping critical documentation accurate, organized, and inspection-ready. We're looking for someone who combines relevant education and/or experience with a proactive mindset, strong judgment, and a commitment to supporting high-quality operations in a regulated manufacturing environment.

Success in this position comes from understanding quality operations and applying cGMP requirements with care and consistency. Strong candidates typically have experience in a pharmaceutical, biotech, or biologics manufacturing setting, along with a basic understanding of aseptic processes.

You'll stand out if you are highly organized, detail-oriented, and confident working within Good Documentation Practices while using tools like Microsoft Word, Excel, PowerPoint, and…