The Role
JOB TITLESUPERVISOR, QUALITY ASSURANCE – QUALITY OPERATIONSDepartmentQuality Assurance – Quality OperationsReports ToManager, Quality Assurance – Quality Operations or aboveLadder Level4 DESCRIPTIONPosition OverviewThe Supervisor, Quality Assurance oversees routine activities associated with 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, in-process sampling / testing, primary and secondary packaging, label control, and document management ensuring procedural and regulatory compliance throughout the manufacturing process. The Supervisor, Quality Assurance will report to the Manager, Quality Assurance or above.Essential Duties and 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 hire 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.
- 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.
- 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 preferred.
- 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.
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The Company
What We Do
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Prademagene zamikeracel (pz-cel) is Abeona’s investigational autologous, COL7A1 gene-corrected epidermal sheets currently in development for recessive dystrophic epidermolysis bullosa. The Company’s fully integrated cell and gene therapy cGMP manufacturing facility served as the manufacturing site for pz-cel used in its Phase 3 VIITAL™ trial, and is capable of supporting commercial production of pz-cel upon FDA approval. The Company’s development portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona’s novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases
