Associate Manager, Quality Assurance, Quality Operations

Abeona Therapeutics•Cleveland, OH

7h•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. 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 an Associate Manager, Quality Assurance, Quality Operations As a Associate Manager, Quality Assurance, Quality Operations at Abeona Therapeutics, your day-to-day activities will focus on overseeing routine activities associated with the manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position 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. This includes in-process sampling / testing, primary and secondary packaging, label control, and document management ensuring procedural and regulatory compliance throughout the manufacturing process. The Associate Manager, Quality Assurance will report to the Manager, Quality Assurance or above. 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 Sunday to Wednesday (10-hour shifts) from 8:00 AM - 6:00 PM (with some late night or weekend work on occasion).

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.
Excellent organizational skills, attention to detail, and Good Documentation Practices.
Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
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.

Nice To Haves

Having a "quality mindset" that has been fine-tuned through at least five years of practical application in a quality role working in manufacturing (pharmaceutical, biotech, or biologics) in a cGMP regulated environment is key to being successful in this role.
Attention to detail and the ability to oversee multiple team members' work to ensure compliance and accuracy, while also ensuring that communication between the quality teams, manufacturing, and other departments is always a top priority.

Responsibilities

Coordinate and facilitate QA-related production and production-related activities.
Prioritize Quality Assurance workload as needed/priorities shift.
Independently address and report on daily operational issues, as needed.
Responsible for new employee training, employee growth and development/guidance and conducting performance reviews in a timely and objective manner.
Review batch-related documentation and ensure resolution of issues to release product.
Perform overall batch disposition and sign product certificate of analysis.
Ensure that products are manufactured in compliance with site procedures, regulatory and cGMP guidelines.
Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
Participate in site inspections and inspection readiness activities.
Enhance skills via regular training and continuing education, including professional society membership/participation.
Completion of gowning qualification and maintaining status for entry into Aseptic processing area.
Must be able to demonstrate a sound knowledge of aseptic gowning practices and support Manufacturing on the floor.
Author, Approve or Authorize documents as assigned. Documents include but are not limited to: Master Production Records, Quality Control test methods/forms, Method Qualification/Validation records, etc. Authorization includes a review of the content for applicability in connection with customer audit/inspections as well as GMP compliance.
Perform other duties as required.