Associate Manager, Quality Assurance, Quality Operations

Abeona Therapeutics Inc.•Cleveland, OH

2d•$85,000 - $90,000•Onsite

About The Position

Join Abeona Therapeutics as an Associate Manager, Quality Assurance, Quality Operations 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 on site four days per week, Sunday to Wednesday (10-hour shifts), from 8:00 AM - 6:00 PM and contribute to impactful products that change peoples' lives. With a competitive salary of $85,000 - $90,000 per year (this range includes base salary and anticipated annual bonus), this 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.

Requirements

Minimum of a Bachelor's degree in related field and/or equivalent experience.
Minimum of 5-7 years of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment.
Working knowledge of quality operations and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
Working knowledge of GCP, GDP, GLP and cGMP regulations and their relevant ISO counterparts and ICH Guidelines
Thorough knowledge of aseptic manufacturing processes.
Thorough knowledge of batch disposition.
Excellent organizational skills, attention to detail, and Good Documentation Practices.
Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
Ability to communicate and work independently with scientific and/or technical personnel.
Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.
Ability to thrive in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.

Responsibilities

Overseeing routine activities associated with the manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH.
Oversees the maintenance of the quality systems in support of a cGMP Operation for production processes relating to batch record review and release from start to end of manufacturing activities.
Includes in-process sampling / testing, primary and secondary packaging, label control, and document management ensuring procedural and regulatory compliance throughout the manufacturing process.