Quality Assurance Document Control & Training Associate

Genezen • Indianapolis, IN

9h

About The Position

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.
WORKING AT GENEZEN
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.
JOB SUMMARY
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.

Requirements

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

Nice To Haves

• Experience with Veeva preferred.
• 1 - 2 years of experience in Document Control or related area preferred
• Bachelor’s degree

Responsibilities

• 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 need 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
• Coordinates onboarding activities for new hires.
• Helps 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.
• Tracks, maintains, and files completed training forms and employee training files.
• Strong interpersonal skills and an ability to interact professionally with team members of various professional levels.

Benefits

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary, vested immediately
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level