Position: Documentation Control Specialist
Department: Quality Assurance
to: Documentation Control
A Documentation Specialist is responsible for maintaining the
quality documentation system for Genus. In this role,
responsibilities include, but are not limited to, the following:
Maintain the documentation control system.
Coordinate the submission, approval, distribution and
archival of all official documentation.
Maintain the master document list, master document files,
electronic document files, and master archival list
Prepare documents in accordance with FDA regulations.
Assist in the preparation of documents for NDA and ANDA
filings and agency audits.
Review and author departmental documentation.
Maintain inventory of executable documents for company use
Any combination of education, training, and experience which
demonstrates the ability to perform the duties and
responsibilities as described.
Confident and clear written and verbal communication skills
with the ability to engage with a diverse range of individuals
across all levels of the organization
Must be able to handle multiple concurrent projects and work
in a fast paced environment. Self-motivation and pro-activity are required.
Proficient in Microsoft Outlook, Word, and Excel, as well as