Senior Specialist, Quality Systems

Abeona Therapeutics • Cleveland, OH

7d • $74,000 - $92,000 • Hybrid

About The Position

The Senior Specialist I, Quality Assurance performs routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This early to mid-career position helps leads the maintenance of the quality systems in support of a cGMP Operations, corrective and preventative actions, quality events management (e.g., nonconformances, deviations, etc.), training, document management, change control, and ensuring procedural and regulatory compliance throughout the manufacturing process. The Senior Specialist I, Quality Assurance will report to the Supervisor, Quality Assurance or above. While there may be some flexibility for remote work, this position requires the candidate be available to work up to five days per week on site. Work outside of usual working hours may be required. Position is Day Shift with occasional weekends (as needed).

Requirements

• Minimum of a Bachelor's degree in related field and/or equivalent experience.
• Minimum of 5 years of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
• Working knowledge of quality systems 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.
• 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.

Nice To Haves

• Previous experience leading CCRB
• Previous experience leading a team to achieve clear results on a project
• 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.

Responsibilities

• Review non-conformances and ensure effective corrective/preventive actions (CAPA) are implemented in a timely manner.
• Write new standard operating procedures or revise existing documentation utilizing document management systems.
• Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
• Develop and present metric reporting and data analysis to help new processes or drive process improvement for quality systems.
• Perform training for new and existing team members, prepare training materials as necessary.
• Support site inspections and inspection readiness activities.
• Ensure the site is audit ready.
• Assists in internal audits of functional areas.
• Lead one of the following with minimal oversight: Document Control, CAPA, Deviations/Investigations, Change Controls, Training, or other key functions and cross train to support other functions.
• Work closely with functional groups to ensure processes and personnel remain in compliance with site procedures, regulatory and cGMP guidelines.
• Prioritize Quality Assurance workload as needed/priorities shift.
• 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
• Compensation (annual): $74,000 - $92,000 (note: total annual compensation listed is based on annual salary and anticipated annual bonus)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees