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.
ESSENTIAL JOB FUNCTIONS
- 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.
- Participates in the development and delivery of effective training materials for GxP, and development functions, as needed.
- 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.
JOB REQUIREMENTS
- Adaptability required as work schedule may change based on business needs.
- Criminal background check required.
- Other duties as assigned.
KNOWLEDGE, SKILLS AND EXPERIENCE
EDUCATION / CERTIFICATIONS / LICENSES
Essential/Desired
Bachelor’s degree or 2-4 years of experience in Document Control or related area preferred
Essential
ON-THE-JOB EXPERIENCE
2-4 years of experience in Document Control or related area
Essential
Experience in GxP environment.
Essential
Document review and GxP procedural writing experience.
Essential
Experience with Veeva
Desired
SKILLS / ABILITIES
Understanding of office processes, including filing, record management and archiving of documentation
Essential
Proficient with Microsoft Word, Excel, Outlook, and Adobe Acrobat.
Essential
Attention to Detail
Essential
Strong communication and customer service approach
Essential
Organizational Skills
Essential
Time Management
Essential
Self-directed and motivated
Essential
Ability to work overtime as needed
Essential
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment
- Regularly sit for long periods of time.
Movement
- Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
- Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
- Frequently lift and/or move up to 10 pounds
- Occasionally lift and/or move up to 25 pounds
Vision
- Frequently utilize close vision and the ability to adjust focus
Communication - Frequently required to communicate by talking, hearing, using telephone and e-mail
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science
We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners
We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S 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
ADDITIONAL DETAILS
- Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- Genezen participates in EVerify.
- Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
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