Lead Specialist, Quality Assurance

Duties:  Lead training program improvement initiatives. Coordinate Training eLMS administrative functions, including processes, logistics, delivery, metrics, and maintenance while identifying and effectively resolving quality issues or discrepancies. Collaborate and assist Functional Areas with creating and maintaining compliant training programs and curriculum. Deliver group and individual instruction and training covering a range of technical, operational, and/or management areas including new hire orientation. Develop training curricula or recommend/utilize vendor programs that meet instructional goals and objectives. Work cross-functionally to formulate training outlines and determine instructional methods, utilize knowledge of specified training needs and effectiveness of such methods as individual training, group instruction, lectures, demonstrations, conferences, meetings, and workshops. Select or develop training aids in collaboration with department management, including training handbooks, demonstration models, multimedia visual aids, computer tutorials, and reference works. Evaluate effectiveness of training and development programs and utilize relevant evaluation data to revise or recommend changes in instructional objectives and methods. Assist in analyzing and assessing training and development needs for individuals and departments. May review instructor performance and recommend improvements to program content and/or instructor presentation methods; may recruit, select, and train instructors. Lead, guide, and train staff/student employees, interns, and/or volunteers performing related work; may participate in the recruitment of volunteers, as appropriate to the area of operation. Work with IT System Owners to troubleshoot issues with electronic systems. Perform daily operations within the eLMS, such as managing training items and curriculum, modifying user accounts, creating reports, and system troubleshooting. Position reports into Cambridge, MA office; however, telecommuting from a home office may also be allowed.

Requirements: Requires a Bachelor’s degree in Health Information Technology, Biotechnology, or a directly related scientific field plus three (3) years of experience organizing or conducting training in a GxP regulated industry. Experience may be gained concurrently and must include:

Three (3) years in each of the following:

- Leading and facilitating trainings for individuals and departments

- Preparing instructional aids and plans

- Applying knowledge of GxP regulations, quality systems, and guidance documents including ICH

- Managing all aspects of training including determining objectives, designing, developing, implementing, and evaluating training plans, curricula, and methodology.

One (1) year in each of the following:

- Working with Document Control

- Utilizing ComplianceWire

- Implementing and validating electronic systems for management of user training.