Specialist I, Quality Assurance, Supplier Quality
About The Position
This Specialist I, Quality Assurance, Supplier Quality role, will perform routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This on-site position supports the release of incoming materials in support of cGMP Operations. The Specialist I, Quality Assurance, Supplier Quality, will report to the Associate Manager, Quality Assurance - Supplier Quality or above. This is an early career position that provides a great entry into a career in Quality! This position is currently five days per week on day shift (occasional weekends as needed), with the potential to change to four, ten-hour shifts in the future (schedules are subject to change based on company need).
Requirements
- Minimum of a Bachelor's degree in related field and/or equivalent experience.
- Minimum of 1 year of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
- Working knowledge of systems and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
- Ability to work effectively and efficiently with minimal supervision.
- Possess basic problem-solving skills.
- 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.
- Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.
Nice To Haves
- Minimum of 1 year of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
Responsibilities
- Adhere to GMP practices.
- Accurately review and approve controlled documents including suppliers Certificates of Analysis or Certificates of Conformity.
- Inspect incoming materials and Abeona Manufactured Materials for accuracy and defects.
- Work closely with other departments to release materials for GMP use.
- Maintain documentation in an organized manner both physically and electronically.
- Maintain a shared, organized workspace.
- Support change controls, as needed.
- Support site inspections, as needed.
- Work closely with functional groups to ensure processes and personnel remain in compliance with site procedures, regulatory and cGMP guidelines.
- 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
- PTO: 160 hours of paid time off per calendar year (Prorated based on date of hire; can carry 40 hours over to the next year)
- Compensation (annual): $60,000 - $75,000 (compensation includes base salary plus anticipated annual bonus)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
