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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

Requirements

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
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