PRINCIPAL OBJECTIVE OF POSITION:
This position is responsible for the accurate and timely processing of all training requests and successful maintenance of the Training System for GMP impacted areas. This position works with Department Managers to maintain current and accurate training curriculum(s) and assignments for GMP employees. This position will provide technical support to the business as required for use of the Learning Management System. The senior specialist assists in determining training solutions that adhere to the Site Training program. Must have the ability to communicate information across all employee levels. This position reports to the Manager, Quality Training, Learning and Development. This role supports Devens CTDO operations. This role is a member of the Quality Systems and Compliance Organization.

MAJOR DUTIES AND RESPONSIBILITIES:

• Utilizes the ServiceNow Ticketing System to then process LMS requests in SuccessFactors. Tickets include:

• Create and maintain GMP curricula

• Utilize approved documents to create On-The-Job (OJT) Items to add to Curricula

• Assigns training and works with groups to build Assignment Profiles

• Process waivers, training equivalencies, training extensions and trainer authorizations

• Supports all Audit requests by running learner reports and or curriculum reports.

• Supports the tactical and strategic training needs of the Devens Cell Therapy Facility.

• Assists within the site Training organization, and as a resource to the functional areas.

• Assists in discussions with functional area representatives, subject matter experts (SMEs), and cross-functional teams to develop and implement key learning strategies and programs in support of Cell Therapy Facility and functionally driven projects where training is positioned as a key success factor.

• Contributes to design and develop training courses based on Training Impact Assessment to determine appropriate methodology.

• Manages the Cell Therapy Quality Training Group Mailbox and triages incoming emails.

• Provides reports/queries/metrics as requested from Learning Management System for compliance and supports miscellaneous requests.

• Collaborates with internal IT to provide LMS troubleshooting.

• Recognizes and resolves training discrepancies. Communicates any such occurrence and corrective action to affected personnel.

• Reviews and approves accuracy of documents for training information and updates document effective dates through company’s Document Management systems (DMS).

• Manages, schedules, and coordinates training for GMP courses.

• Maintains Curriculum Catalog on all curricula data that is inputted into the LMS to ensure integrity across all users.

• Updates Training SharePoint with employee training status towards Maximo system role requests.

• Authors documents regarding LMS processes, policies, and training in DMS as necessary.

• Acts as a support fielding questions and issues from internal customers related to the business and systems.

• Files all training documentation (hard copy) and provides general administrative support of department as required.

• Trains new team members and provides one-on-one coaching to LMS learners, management, or designee.

• Contributes to completion of training system-related objectives as assigned.

• Performs other tasks as assigned.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree required

• 5 or more years of relevant systems experience in a regulated industry required, preferably in Life Sciences.

• Learning Management System (LMS) background required. SuccessFactors strongly preferred. ComplianceWire desirable.

• Experience in ServiceNow or equivalent ticketing system.

• An equivalent combination of education and experience may substitute.

• Knowledge on Good Manufacturing and Documentation Practices.

• Detail oriented.

• Experience in training material development and training delivery.