Massachusetts Information Technology Jobs

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