Lead Document Control Specialist

About Genetix Biotherapeutics

At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

SUMMARY

The Lead Document Control Specialist is considered an expert in their knowledge of Document Control processes, who possesses broad knowledge and can lead multiple projects with a high degree of independence.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

• Maintain the document control system, including lifecycle management of paper and electronic records


• Review new and revised controlled documentation for appropriate format, content and consistency with other documentation and compliance to document control procedures


• Lead the development of document review standards & conventions


• Drive improvements and efficiencies with a high degree of initiative and independent judgement related to the document management process, including system updates


• Lead the development of templates, tools and procedures for the global Document Control function


• Contribute to innovative solutions to create efficiencies and educate the customer base


• Serve as Subject Matter Expert and Qualified Trainer of SOP Development and other instructor led courses


• Manage the indexing, storage and retrieval of records within the QA Archive and at off-site document storage facility/ies


• Work with stakeholders and customers to ensure appropriate document management, use, standards application and control


• Provide support for all documentation control activities


• Provide support during audits of regulatory agencies; Other duties as assigned

 QUALIFICATIONS

• BS/BA with 5-7+ years of document control experience supporting documentation programs and systems in pharmaceutical or biopharmaceutical industries.


• Technical writing experience a plus; expertise in SOP Development and the ability to train personnel on related concepts


• Strong knowledge GxP regulations, quality systems (Document Control, Training)


• Must have excellent attention to detail, project and time management skills as well as the ability to manage multiple priorities with aggressive timelines with minimal supervision


• Excellent interpersonal, teamwork, and organizational skills


• Expert proficiency with Microsoft products and document publishing software (e.g. Excel and Adobe Pro); must be able to learn additional applications as needed. Veeva QDocs experience is a plus.

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.