Document Control Specialist

Company: Neurogene Inc.

Brief Description

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.

Position Overview

The applicant will be a team player in a small company environment in this highly cross-functional role. Reporting to the Manager, Quality Systems, this person will manage the creation, revision, issuance and archival of controlled documents within the company’s Quality Management System and manage Neurogene’s document archive to ensure GxP compliance and quality oversight. This role will collaborate across the company to support the filing and archiving of GXP documentation essential to the success of the company.

Requirements

• Leads the establishment and maintenance of the company’s archive.
• Administers the document control process in the eQMS and/or paper-based system.
• Assists in developing, implementing, and/or improving archive quality processes and systems.
• Scans, reconciles and archives executed documents.
• Manages archive reviews and audits as necessary.
• Retrieves and prints controlled documents as requested.
• Performs periodic reviews of controlled documents to ensure accuracy and relevance.
• Supports internal and external audit/inspection requests for document retrieval.
• Assists in continuous improvement of document control workflows and systems.
• Supports the goals and objectives of the Quality organization.
• Performs other duties as assigned.

Minimum Requirements

Education

• Bachelor’s degree in life sciences (Chemistry, Biology, Microbiology, Biochemistry), pharmacy or related engineering field.

Experience

• 2-4 years of relevant experience in the biotech/pharmaceutical industry.
• Experience with electronic document control and/or training software is required (Veeva is preferred).
• Expertise in Microsoft Office suite of applications, particularly Access, Outlook, Word, Excel.

Knowledge, Skills & Attributes

• Working knowledge of GxP requirements for documentation and document archival.
• Ability to interpret GxP requirements.
• Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at the same time, including the ability to follow assignments through to completion and meet deadlines.
• Excellent communication (verbal and written) skills required.
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results.
• Ability to track and measure performance against defined metrics.
• Self-starter with a high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team.
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company.
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families.