Editas Medicine Senior Training Specialist Quality Systems in Cambridge, Massachusetts
Key Responsibilities & Accountabilities:
Revise training SOP’s and work instructions when necessary
Administer the ComplianceWire electronic Learning Management System (eLMS)
Perform the responsibilities required to maintain and continuously improve the eLMS (ComplianceWire)
Supports all training activities within the Quality Systems team for the entire company
Supporting the document lifecycle training process
Developing and delivering site wide GxP refresher training
Perform New Employee Quality Systems Orientation
Create classroom Quality System training presentations
Create online, ondemand captivate interactive trainings
Monitor and report training on-time performance
Support the development of on-the-job training and employee curricula
Keep up to date on industry best practices
Develop Management Review training metrics slides on a periodic basis
Support the validation of the eLMS when changes to the validated state are made
Knowledge, Skills & Capabilities:
Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
Working knowledge of current Good Manufacturing Practices (cGMP – 21 CFR Part 210/211) and Electronic Records; Electronic Signatures (21 CFR Part 11).
Proficiency in the use of Microsoft Office, PowerPoint, electronic document (Veeva Quality Docs) and Training (ComplianceWire) systems.
Experienced in development of online, on demand trainings using such tools as Adobe Captivate
Experience with management and implementation of e-Quality Systems.
Good Presentation development and performance skills.
Good verbal and written communication skills
Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives
Demonstrated organizational skills to managing multiple projects and priorities.
Education & Relevant Work Experience:
BS Degree in Life Sciences or equivalent
Minimum of 5 yrs. exp. in training in a GxP environment and minimum of 5 yrs. working in a GMP environment or equivalent experience.
Physical & Travel Requirements:
- Travel 15% of the time