Sr. Specialist , Quality Assurance - Quality Operations

Sr. Specialist I, Quality Assurance
- Quality Operations

The Senior Specialist I, Quality Assurance performs routine activities associated with the development of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position will provide Quality oversight and support for Assay Development, Process Development, Design Control, R&D, Validation, continuous improvement initiatives, and life cycle management projects. The successful candidate will bring a strong understanding of cGMP, Quality Systems, and regulatory expectations within the cell and gene therapy space.

The Senior Specialist I, Quality Assurance will report to the Associate Manager, Quality Assurance or above and will support Assay Development, Process Development, Validation, and R&D as the functional group Quality Assurance representative.

Essential Duties and Responsibilities:

• Review and Approvals:
• Study protocols and summary reports for Assay Development, Process Development, and Validation activities.
• Validation documentation (IOQ, IOPQ, Commissioning, OQ, etc.).
• Method qualification/validation protocols and reports and ensure resolution of and discrepancies that occurred during execution.
• Quality Oversight:
• New method development and method bridging activities.
• Design control elements, including risk management and design verification/validation documentation.
• Support continuous improvement initiatives across QA and cross-functional teams, contributing to system and process enhancements.
• Ensure Quality compliance in life cycle management projects by reviewing changes, assessing impact, and participating in cross-functional reviews.
• GDP
  - Document Controls:
• Process document control requests and issue-controlled forms, logbooks, notebooks, master production records, labels, and protocols.
• Reconcile issued controlled forms, logbooks, notebooks, master production records, and protocols.
• Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
• 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, Development Reports, etc. Authorization includes a review of the content for applicability in connection with customer audit/inspections as well as GMP compliance.
• Site
  
  Collaboration:
• Collaborate with R&D, Manufacturing, QC, and Regulatory Affairs to ensure Quality is integrated early in development stages.
• Support site inspections and inspection readiness activities.
• Personal Development:
• Enhance skills via regular training and continuing education, including professional society membership/participation.
• Perform other duties as required.

Qualifications:

• Minimum of a Bachelor's degree in related field and/or equivalent experience.
• Minimum of 5 years of experience in quality assurance or quality engineering in a pharmaceutical, biotech, biologics, or medical device cGMP regulated manufacturing environment preferred.
• Knowledge of FDA and EU regulations, ICH guidelines, and cGMP/cGTP requirements.
• Experience supporting Design Control and product development processes.

Other required competencies:

• 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, and work independently with scientific and/or technical personnel.
• Ability to thrive in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to…