Document Control Specialist, Quality Assurance, Quality Systems

Abeona Therapeutics • Cleveland, OH

3d • Hybrid

About The Position

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. 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. 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. 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.

Requirements

• Minimum of a Bachelor's degree in related field and/or equivalent experience.
• Minimum of 1-3 years of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
• Working knowledge of quality operations and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
• Basic knowledge of aseptic manufacturing processes.
• Strong foundation in quality and compliance.
• Ability to work with precision and take pride in keeping critical documentation accurate, organized, and inspection-ready.
• Proactive mindset, strong judgment, and a commitment to supporting high-quality operations in a regulated manufacturing environment.
• Understanding of quality operations and ability to apply cGMP requirements with care and consistency.
• Highly organized, detail-oriented.
• Confident working within Good Documentation Practices.
• Ability to use tools like Microsoft Word, Excel, PowerPoint, and Office 365 to manage documentation efficiently.
• Communicate clearly.
• Collaborate well across teams.
• Stay professional under pressure.
• Ability to adapt quickly in a fast-paced, patient-focused environment with changing priorities.
• Applicants must be authorized to work for ANY employer in the U.S.
• Not suitable for someone whose work authorization is temporary and based on optional practical training (OPT).
• Current or future H-1B sponsorship is not available for this role.

Nice To Haves

• Experience in a pharmaceutical, biotech, or biologics manufacturing setting.
• Basic understanding of aseptic processes.

Responsibilities

• Editing, formatting, and proofreading documents prior to SME approval in the Quality Management System.
• Supporting all document review and retention/archiving for the site.

Benefits

• Medical insurance
• Company covered basic Dental insurance
• Company covered basic Vision insurance
• HSA options
• FSA options
• Lifestyle Spending Account
• 401k options
• Company match program for 401k
• Up to 160 hours of Paid Time Off per calendar year
• Healthy snacks and beverages
• Sweets

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level