Quality Assurance Document Control & Training Associate

Quality Assurance Document Control & Training Associate

Indianapolis, IN

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast‑growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work.

Every employee contributes to the success of the company and you can be part of that team.

The QA Document Control/Training Associate will support both the GxP and development areas of Genezen for aspects related to document management and training. The role is expected to work proactively with various departments to help ensure understanding of training, document management procedures and software to ensure that documentation requirements are consistently met in a timely manner.

• Perform document administrator functions within Electronic Document Management System
• Format Documents in accordance with approved templates and procedures
• Issue and verify controlled documents and unique identifiers (including lot numbers and labels)
• Perform archival, scanning, and tracking of physical documents
• Revise/Develop policies and procedures for document control system in support of Quality Management System as needed
• Submit and request documents to/from off‑site storage
• Provide support and training as needed for use of the EDMS
• Provide support for inspections including tracking inspection requests, document retrieval, and generation of official copies
• Track documents relative to expiration/review periods
• Maintain training on documents relative to job functions
• Perform other related duties and responsibilities as needed
• Coordinate onboarding activities for new hires
• Help maintain and improve onboarding process for new hires
• Assist with Training Department requests including, but not limited to: report requests, training verifications, training approvals, updates in the EDMS, etc.
• Track, maintain, and file completed training forms and employee training files
• Strong interpersonal skills and an ability to interact professionally with team members of various professional levels

• Experience in GxP environment
• Document review and GxP procedural writing experience
• Proficient with Microsoft Word, Excel, Outlook, and Adobe Acrobat
• Experience with Veeva preferred
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

On‑the‑Job Experience

1–2 years of experience in Document Control or related area preferred

• Understanding of office processes, including filing, record management and archiving of documentation
• Attention to Detail
• Strong communication and customer service approach
• Organizational Skills
• Time Management
• Self‑directed and motivated
• Ability to work overtime as needed

While performing the duties of this job, the employee is required to meet the following physical demands:

• Regularly sit for long periods of time
• Frequently stand, sit, walk, balance, stoop, kneel, crouch, use hands to finger, handle, or feel, reach with hands and arms
• Occasionally walk, climb or balance; and stoop, kneel, crouch, or crawl
• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds
• Frequently utilize close vision and the ability to adjust focus
  Communication
• Frequently required to communicate by talking, hearing, using telephone and e‑mail

• Committed to Science – We are committed to scientific excellence, staying current with industry developments, making data‑driven decisions, and pursuing innovation to advance healthcare.
• Urgenc…