o Provide Training to admin staff (QAs) and Managers to perform tasks within LMS pertaining to their role.
· Assist with vendors that provide additional services related to the LMS, such as hosting, maintenance, or training material content.
· Ability to work with cross-functional teams to manage the LMS.
· Compile, generate, and present metrics routinely.
· Perform trend analysis to monitor training effectiveness.
· Oversee employee completion of training.
· Train upon, manage, and author SCORM.
· Assist with implementation and validation of API functionality.
· Assist in onboarding and offboarding of personnel and processes, along with the aid of Human Resources (HR).
· Assist in the creation and administration of materials to be distributed during training.
· Assist in other electronic system integrations, including training.
· Liaison with the sites to create site specific trainings, as required.
· Build training curriculums for positions, products, etc. in collaboration with SMEs.
· Perform general training on SOFIE processes and products in manufacturing and pharmacy to understand SOFIE operations. For example, SOFIE general company overview and other topics, as assigned by Associate Director, Training.
· Manage training workflows in LMS (or other training mechanisms) to ensure they are completed on time and by the required staff.
· Assist in ensuring training plans for new employees are followed.
§ Assist administratively with training courses, workshops, manuals, procedures, and other training needs of the organization.
§ Assist with the coordination, oversight, and scheduling of annual trainings, such as Annual CGMP Training, Aseptic Techniques, Good Documentation Practices, Data Integrity, Complaint Handling, etc.
§ Assist in the review, formatting, and administration of tests, quizzes, and polls, after the completion of training courses to determine the effectiveness and/or contentment of training strategies.
§ Asist in the generation or review of CGMP documentation.
§ Drive SOFIE values and philosophy through all training and development activities.
§ Effectively communicate with team members, trainers, management and external parties.
§ Assist with the closure and completion of corrective and preventive actions, change controls, and exception documents that reference training.
§ Other responsibilities as required.
§ Available to travel 25% of his/her time.
Qualifications
§ Bachelor’s Degree (IT or life science preferred).
§ 1-2 years’ experience administering a learning management system or lab information system preferred.
§ Knowledge of USP, FDA, and CGMP regulations preferred.
§ Knowledge of how and ability to write, review, and revise SOPs required.
§ Familiar with Learning Management Systems (LMS).
§ Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, inspectors, and the general public required.
§ Ability to define problems, collect data, establish facts, and draw valid conclusions required.
§ Ability to solve problems and handle issues required.
§ Proficiency in MS Office applications and related business and communications tools required.
§ High proficiency in PowerPoint required.
§ SCORM and API experience preferred.
§ Strong interpersonal communication skills.
§ Critical thinker with innovative problem-solving skills.
§ Strong organizational and time management skills.
§ Strategic and creative mindset.
§ Meticulous attention to detail.