Supervisor, Quality Assurance
Supervisor, Quality Assurance
Abeona Therapeutics
Cleveland, OH
See who Abeona Therapeutics has hired for this role
- 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
Powered by JazzHR
cNX0iJ4hOe
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Quality Assurance -
Industries
Internet Publishing
Referrals increase your chances of interviewing at Abeona Therapeutics by 2x
See who you knowGet notified about new Quality Assurance Supervisor jobs in Cleveland, OH.
Sign in to create job alertSimilar jobs
People also viewed
-
Production Supervisor
Production Supervisor
-
Production Supervisor - Second Shift
Production Supervisor - Second Shift
-
Production Supervisor
Production Supervisor
-
Production Supervisor
Production Supervisor
-
Technical Operations Supervisor
Technical Operations Supervisor
-
Production Supervisor
Production Supervisor
-
Production Supervisor - Night Shift
Production Supervisor - Night Shift
-
Metal Stamping 1st Shift Set-Up & Production Supervisor
Metal Stamping 1st Shift Set-Up & Production Supervisor
-
Production Supervisor
Production Supervisor
-
Production Supervisor
Production Supervisor
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More