Sr. Specialist I, Quality Assurance - Quality Operations
About The Position
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.
Requirements
- Minimum of a Bachelor's degree in a 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.
- Knowledge of FDA and EU regulations, ICH guidelines, and cGMP/cGTP requirements.
- Experience supporting Design Control and product development processes.
- 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.
- Must be authorized to work for ANY employer in the U.S. Cannot sponsor or take over sponsorship of an employment Visa.
- Work authorization cannot be temporary and based on optional practical training (OPT).
- Current or future H-1B sponsorship is not available for this role.
Nice To Haves
- Strong scientific background.
- Advanced degree within a life science or engineering field.
- Lab bench experience.
Responsibilities
- Review and approve study protocols and summary reports for Assay Development, Process Development, and Validation activities.
- Review and approve validation documentation (IOQ, IOPQ, Commissioning, OQ, etc.).
- Review and approve method qualification/validation protocols and reports, ensuring resolution of discrepancies.
- Provide quality oversight for new method development and method bridging activities.
- Provide quality oversight for 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.
- 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, including Master Production Records, Quality Control test methods/forms, Method Qualification/Validation records, and Development Reports.
- 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.
- Enhance skills via regular training and continuing education, including professional society membership/participation.
- Perform other duties as required.
Benefits
- Medical insurance coverage (multiple options to meet our employees' and their families' needs)
- Dental and vision coverage
- 401k match plan
- Lifestyle spending account
- 160 hours of paid time off per calendar year (Prorated based on date of hire; can carry 40 hours over to the next year)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
11-50 employees
