Quality Assurance Specialist
Great opportunity to be part of a dedicated team building capability to serve the rapidly expanding gene therapy market. Vector Biomed aims to become a leading supplier of high-quality Lentiviral vectors for research and clinical use. Team members will support cGMP manufacturing in a dynamic new company setting.
We are seeking a person experienced in the development, implementation, and management of Quality Management Systems (QMS), including Document Control, Training, and management of Quality Events.
The Quality Assurance Specialist will assist in the establishment of an electronic Quality Management System (eQMS) to provide essential Quality Systems in support of cGMP manufacturing. Key elements of the QMS system will include document control, employee training, change management and various Quality Events (nonconformances/deviations, corrective actions, investigations, etc.).
- Facilitate the life cycle of controlled documents in the electronic document management system (document creation, revision, archival, retention and withdrawal/retirement)
- Manage document control processes through electronic systems and/ or paper base systems. Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks.
- Inform management of deviations and assist in determining appropriate CAPAs as needed; verify that assigned actions have been implemented.
- Trains departmental staff in eQMS procedures and cGXPs
- Support internal external, and client audits and regulatory inspections
- Reports status of process performance and provides monthly Quality metrics
- BS/BA and a minimum of 3 years relevant experience in a QMS role.
- Hands-on knowledge with issuing GMP batch records, logbooks, and/or other controlled documents
- Excellent organizational skills and attention to detail
- Experience with eQMS systems in pharmaceuticals and/or biotech, preferred
- Working knowledge of GMP basics, FDA guidance, and industry best practices
- Ability to operate efficiently and effectively in a fast-paced environment
- Proficient with the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe