Senior Training Specialist
Title: Senior Training Specialist
Type: Contract to perm
Duration: 6 months
Location: Waltham, Massachusetts
Top 3 Technical Skills:
• GXP & experience supporting audits
• at least 3 years of supporting Learning & Development
• Experience with the Regulations
The Sr. Training Specialist is responsible for oversight of the GxP Training Program. This role will also by a key player in implementing and administering the new Cornerstone Learning Management System (LMS). If successful, role may convert to QA Training Program Manager within 6-9 months.
Under the direction of the QA Systems Training Manager, the Quality Systems Sr. Training Specialist will-
Assist with the implementation of company-wide LMS (CornerStone).
Collaborate with Document Owners to guide Training Evaluations for new and revised documents, including exam/ material creation, audience identification and assignment/ deployment.
Maintain the LMS with the assignment of curricula and trainings. Provides system support to users.
In conjunction with Functional Area Management and Global Learning, establish various types of audience profiles and work with leadership to define applicable curricula for various audiences.
Establish a GxP Training Program, including creation of training materials designed for New Hire Orientation, Refresher training, and others.
Develop and implement competency-based training modules (Doc Authoring, Change Control, Deviation Management, Batch Record Review, and others).
Establish standard set of training metrics and measurements for Sr. Leadership.
Support GxP audits and inspections.
Develop and implement action plans derived from training related Deviations, CAPAs, and Change Controls.
Develop new training procedures and revises existing procedures as required.
Bachelor’ s Degree in a Scientific or Education major.
Must have 5-8 years’ experience working in a GXP environment with 3 years experience supported training and development
Strong understanding of GxP requirements & Quality Systems.
Strong Computer & Information Technology Skills (Word, Excel, Power Point, Visio, BrainShark)
Experience administering one or more LMS’ s is required. Cornerstone LMS highly preferred.