Document Control Specialist, Quality Assurance, Quality Systems

Abeona Therapeutics Inc.Cleveland, OH
$62,000 - $65,000Hybrid

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.

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.
  • Highly organized, detail-oriented.
  • Confident working within Good Documentation Practices.
  • Communicate clearly.
  • Collaborate well across teams.
  • Stay professional under pressure.
  • Can adapt quickly in a fast-paced, patient-focused environment with changing priorities.

Nice To Haves

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

Responsibilities

  • Support all document review and retention/archiving for the site.
  • Edit, format, and proofread documents prior to SME approval in the Quality Management System.

Benefits

  • Medical insurance
  • Company covered basic Dental insurance
  • 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
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