0545 Training Specialist II

Duties:
The Company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
These individuals build and maintain company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Role Summary:
The Training Specialist II’s primary function is to ensure our Learning Management System (LMS) is effective and efficient.
They will interact with stakeholders and personnel to streamline curricula within the LMS. They will ensure that personnel are adequately credited for the training necessary to perform their functions, assist in identifying and implementing improvements to processes that will lead to gained efficiencies and reduce costs properly and consistently.
This position reports through the Learning & Development function within the Business Operations Department.

Duties:
LMS Administration:
Building training curricula in association with the customer department/group.
Processing of training assignment requests, including curricula and user group creation and modification.
Processing Node structure changes and the associated re-grouping of personnel.
Logging training record data for non-LMS driven activities.
Integrating multiple types of e-Learning training modules into the LMS (i.e. SCORM).
Creation, editing and archive of documentation as directed by department management.
Creation and delivery of custom reports as requested.
Building efficiencies into LMS administration activities.
Contractor Onboarding:
Provide contractor cleanroom and utility yard support for the Contingent Worker access to GMP facilities.
Provide general guidance to contractors, managers, and sponsoring groups Ensuring contractors have the correct curricula assignments, documenting contractor training completion on paper and via the LMS.
Arranging for reinstatement of contractor badge access to restricted areas with Security
Additional Responsibilities:
Support internal/external audits, inspections, and inspection readiness.
Provide support and oversight of course development, training structure, and design.
Generate training reports, provide monthly metrics, and other reports as requested.
Review documents (SOPs) and TCRs, provide feedback on the contents, and assess the training needs and requirements for new and revised procedures.
Deliver onsite and virtual training as applicable.
Lead or support improvement projects for training systems or programs.
Other duties as assigned.

Skills:
Detailed knowledge of LMS and current Good Manufacturing Practices (GMP).
Excellent attention to detail, documentation, written and verbal communication skills are essential.
Experience leading investigations and writing technical investigation reports is an advantage.
Experience with the ComplianceWire learning management system is preferred.
Expertise with quality management systems such as VeevaDocs and VeevaQMS is preferred.
Experience with SNOW ticketing system and Articulate Storyline 360 is preferred.
Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
Must possess the ability to perform routine and non-routine tasks under minimal supervision.

Education:
2-5 years’ experience in a regulated industry with a postgraduate and or working qualification in learning and development, technical training, or instructional design.

Compensation range: $35 to $45.50 /hr