Quality Assurance Document Control & Training Associate

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 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.

• 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.

Bachelor’s degree

Desired

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

Desired

Understanding of office processes, including filing, record management and archiving of documentation

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

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

 

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.

• 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.