Quality Assurance Specialist

1 day ago


Gaithersburg, Maryland, United States Vector BioMed Full time

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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