The Document Control & Training Sr. Specialist will manage Document Control activities for GeneFab and perform training-related tasks to support the Training Program. This individual will advance and implement document management processes as well as perform document administration tasks in Veeva QualityDocs, ensuring that documents are in compliance with GxPs and with Good Documentation Practices. The Document Control & Training Specialist will also perform training-related tasks in the Learning Management System (Veeva Training) as needed. This individual will interact closely with internal stakeholders such as Quality Assurance, Quality Control, MSAT, Manufacturing and Supply Chain.
Experience with Veeva Doc Control and Training Modules is preferred.
Responsibilities:
Manage, plan, and coordinate document control activities and processes, geared towards the quality and manufacturing organization. Lead Document Control compliance and process improvement efforts. Manage documentation by processing, formatting, issuing the documents for training, and making the process effective and accurate. Support the reconciliation and archiving process of paper documents. Responsible for reviewing Document Change Controls to ensure proper revision control of records and closure. Manage the document periodic review process and coordinate with the stakeholders on its completion. Perform Business Administrator activities in the electronic document management system (Veeva QualityDocs). Execute user test scripts for the electronic document management system during changes to the systems Manage Learner Roles, curriculums, and training requirements in the Learning Management System (Veeva Training). Support onsite audits/ and or in any regulatory or client inspections. Perform other projects related to the improvement of quality systems as needed and required by management, including the Veeva eQMS system. Other related duties may be assigned or taken on as needed.
Requirements:
Bachelor’s degree or higherMinimum 5 years of experience in a quality assurance role in the pharmaceutical industry required Experience with EDMS and LMS systems, preferably Veeva Quality Docs and Veeva Training Excellent knowledge and understanding of applicable GxP regulationsExperience in the identification and resolution of Good Documentation Practices issues Familiarity with Microsoft Office Suite, Docusign, Smartsheets, Sharepoint, Adobe Pro, etc.Ability to work in a fast-paced environment with excellent multitasking skills. Must have attention to detail. Works with minimal supervision. Must have effective technical writing skills. Requires excellent organizational, interpersonal, and communication skills. Must exhibit professional behavior and be aware of the importance of teamwork within the assigned department
About GeneFab
GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.
We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
