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Document Control Specialist, Quality Assurance, Quality Systems

Remote · Spain Full-time

Abeona Therapeutics is a mission-driven organization devoted to putting patients first. They are seeking a Document Control Specialist I to ensure that their health care solutions meet the highest quality standards by focusing on document review and management within a regulated manufacturing environment.

Responsibilities

  • Document review which includes, but is not limited to: editing, formatting, and proofreading prior to SME approval in the Quality Management System
  • Support all document review and retention/archiving for the site

Skills

  • 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

Benefits

  • An annual discretionary bonus
  • Medical insurance coverage (multiple options to meet our employees' and their families' needs)
  • Dental and vision coverage
  • 401k match plan
  • Lifestyle spending account
  • PTO: 160 hours of paid time off per calendar year (Prorated based on date of hire; can carry 40 hours over to the next year)
  • 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)
  • Up to 160 hours of Paid Time Off per calendar year
  • Healthy snacks and beverages, as well as a few good, old-fashioned sweets

Company Overview

  • Abeona Therapeutics develops gene therapy-based potential cures for Sanfilippo syndrome types A and B. It was founded in 1989, and is headquartered in New York, New York, USA, with a workforce of 201-500 employees. Its website is http://abeonatherapeutics.com.
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