Job Description Quality Assurance Specialist (Level commensurate with experience).

General Overview:

An exciting opportunity for a Quality Professional seeking an active role in building and administering Quality Systems to support our cutting-edge gene therapy manufacturing operations. We are a small, dynamic organization poised to become a force in the Cell and Gene therapy CDMO space. We are seeking individuals experienced in the development and administration of Quality Management Systems (QMS), including Document Control, Training, and management of Quality Events in a cGMP setting.

Primary Responsibilities:

Administer and support use of electronic QMS system.

Support the life cycle of controlled documents in the electronic document management system (document creation, revision, retirement)

Facilitate initiation, progression and closure of Quality Events within the QMS

Inform management of nonconformances and assist in determining appropriate CAPAs as needed; verify that assigned actions have been implemented; and effectiveness checks are meaningful and effective.

Support material and batch release.

Train departmental staff in eQMS procedures and cGXPs concepts and procedures.

Support internal, external, and client audits and regulatory inspections.

Requirements

BS/BA and a minimum of 3 years relevant experience in a QA 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