Document Control Specialist, Quality Assurance, Quality Systems
$62,000–$65,000 year
Hybrid · Cleveland, Ohio, United States
Job Summary
Document Control Specialist I at Abeona Therapeutics supports routine document review, editing, formatting, and proofreading prior to SME approval within the Quality Management System, plus retention/archiving for the site. The role emphasizes cGMP compliance, Good Documentation Practices, and collaboration across teams to maintain inspection-ready documentation for manufacturing of cell and gene therapy products. The position is based in Cleveland, OH with a mix of onsite and remote work (remote days require manager approval). Proficiency with Microsoft Word, Excel, PowerPoint, and Office 365 is expected, along with strong organizational skills, attention to detail, and the ability to operate in a regulated manufacturing environment. The usual schedule is first shift, Monday to Friday, with potential late or weekend work as needed. A competitive salary of $62,000-$65,000 plus discretionary bonus and comprehensive benefits package is offered, with opportunities for career growth in a values-driven organization.
Required Qualifications
- 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.
Additional Requirements
- Visa Sponsorship Not Currently Available
- Current or future H-1B sponsorship is not available for this role.
- Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
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