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 Office 365 to manage documentation efficiently. Just as important, you communicate clearly, collaborate well across teams, stay professional under pressure, and can adapt quickly in a fast-paced, patient-focused environment with changing priorities.
Essential Duties and Responsibilities
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Position is Day Shift with weekends (only as needed).
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Performs the following duties with minimal supervision.
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Manage the process for the creation, review, editing, and formatting of all GxP controlled documents prior to approval in the Quality Management System per Abeona Style Guide and/or applicable templates. Documents include but are not limited to, master production records, Quality Control test methods, forms, standard operating procedures, protocols and reports, etc.
- Manage electronic document management system (DMS) document lifecycle workflows and assignment of reviewers and approvers
- Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
- Format and proofread new documents to ensure compliance with approved templates, procedures, and DMS requirements.
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Provide guidance to document initiators, owners, and users to ensure compliance with all applicable procedures / regulations, formats, and assist users with DMS workflow related issues.
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Support site inspections, as needed.
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Perform other duties as required.
Required Qualifications
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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.
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Basic knowledge of aseptic manufacturing processes.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional work in laboratory, cleanroom, or manufacturing environments may be required. Occasional lifting up to 25 pounds is required. May require wearing appropriate personal protective equipment (PPE) when entering GMP or lab areas. Occasional walking, standing, or climbing stairs within office or facility settings. Must be able to travel between company sites or to vendor locations, if needed.
Important Notes for Candidates:
Visa Sponsorship Not Currently Available
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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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This is a career-path role that is not suitable for someone whose work authorization is temporary and based on optional practical training (OPT).
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Current or future H-1B sponsorship is not available for this role.
Additional Notes to Applicants:
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Due to the volume of applications received, we are unable to respond to every applicant. Only candidates whose qualifications most closely match the requirements of the position and who successfully complete the initial stages of the selection process will be contacted.
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All applications will be reviewed in accordance with applicable federal, state, and local employment laws.
EEOC Disclaimer
We're committed to building a workplace where everyone feels welcome. We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, gender identity or expression, sexual orientation, age, disability, veteran status, or any other protected status.
Connect with our team today!
If you're ready to take your career to the next level and join a team that values hard work and changing lives - complete our application today!
