Quality Assurance Document Control & Training Associate

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.
• 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.

SPECIAL JOB REQUIREMENTS

• 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.

KNOWLEDGE, SKILLS AND EXPERIENCE

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