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.