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Senior Associate, QA Training - Contractor

Department: QA
Location: Cambridge, MA

Job Scope & Purpose:

Reporting to the AD, GxP Documentation and Training, the QA Training Senior Associate will manage day to day use of our learning management system to ensure effective implementation of our Training Process with all GxP employees. The Associate will develop, deliver, and track programs to enhance end user understanding of processes required to successfully fulfill their job roles. Additionally, the Associate is responsible for providing first-line user support and ensure training processes are aligned with company policies and regulatory requirements.

Primary Job Responsibilities:
Support implementation of GxP Training Process using both electronic and paper-based processes.
Interact directly with Trainees, Managers, and Subject Matter Experts in the roles of Trainer, LMS Administrator, and Instructional Designer to design, develop, and facilitate or deliver general and technical training content (including new hire cGMP training).
Evaluate training needs and participate in the acquisition or development of training materials company-wide.
Partner cross-functionally with business groups to develop employee job training requirements, providing guidance as required.
Develop and maintain training performance metrics and continuously evaluates the effectiveness of training programs. Track status of compliance to training requirements and reports to management.
Coordinate third party delivery of select courseware.
Participate in cross-department initiatives as GxP Training Process resource.
Support audits and regulatory inspections as required.

Primary Job Requirements:
Undergraduate in life science or education field (equivalent).
Minimum 5-8 years of relevant GxP Quality and/or Training experience.
Experience in training and associated Quality Systems and ensuring training compliance.
Experience working with electronic Learning (LMS) and Document Management Systems (eDMS).
Direct experience in courseware development and delivery, including eLearning/CBT applications and design principals.
Deliver training content independently to small and large groups utilizing Adult Learning methodologies.
Contribute positively in a collaborative team environment yet act independently as needed.

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