Quality Assurance Specialist
1 day ago
Job Title: Quality Assurance Specialist
About the Role:
We are seeking a highly skilled Quality Assurance Specialist to join our team at Vector BioMed. As a Quality Assurance Specialist, you will play a critical role in building and administering Quality Systems to support our cutting-edge gene therapy manufacturing operations.
Key Responsibilities:
• Administer and support the use of electronic Quality Management Systems (eQMS) to ensure compliance with regulatory requirements.
• Support the life cycle of controlled documents in the electronic document management system, including creation, revision, and retirement.
• Facilitate the initiation, progression, and closure of Quality Events within the eQMS.
• Inform management of nonconformances and assist in determining appropriate Corrective Actions (CAPAs) as needed.
• Support material and batch release, ensuring compliance with Good Manufacturing Practices (GMPs).
• Train departmental staff in eQMS procedures and cGMP concepts and procedures.
• Support internal, external, and client audits and regulatory inspections.
Requirements:
• Bachelor's degree in a relevant field and a minimum of 3 years of experience in a Quality Assurance role.
• Hands-on experience issuing GMP batch records and other controlled documents.
• Experience with eQMS systems in pharmaceuticals and/or biotech, preferred.
• Working knowledge of GMP basics, FDA guidance, and industry best practices.
• Excellent organizational skills and attention to detail.
• Excellent written and verbal communication skills.
• Ability to operate effectively in a fast-paced environment.
• Proficient with the Microsoft suite (i.e., Word, Excel, Visio, PowerPoint, etc.) and Adobe.
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