This position is part of the Quality Systems Service organization. This position supports the ComplianceWire LMS for the worldwide Keenova Specialty Brands organization. The LMS is the infrastructure that delivers and manages instructional content, identifies, and assesses individual and organizational learning or training goals, tracks the progress towards meeting those goals, and collects and presents data for supervising the learning process of the organization as a whole. This includes efficient and accurate:
" Configuration
" User Profiles
" User Groups
" Training Items
" Curriculums and Assignments
" Reports
Essential Functions
" Support the Learning Management System (LMS) platform across the organization including logistical requirements, support of the day to day and ongoing operation, maintenance, usage, analysis, and administration.
" Maintain the quality management system training elements to comply with relevant regulations, company guidance/policies and relevant international standards such as ISO etc.
" Serve as a knowledgeable resource to customers on implementing quality system training processes and procedures as appropriate and work directly with all sites to ensure quality system training requirements are understood and implemented effectively.
" Provide data about site usage and other key metrics as requested by management and provide valuable input for continuous improvement of metrics.
" Generate standard, ad hoc, custom, and scheduled reports as needed by the business. Run, download, and analyze these reports as needed.
" Participate in the development and implementation of systems, processes, policies, and procedures designed to meet or exceed internal and external requirements related to quality systems training.
" Provide support during internal audits and external regulatory inspections.
" Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues related to training.
" Other duties as assigned.
Minimum Requirements
Education / Experience / Skills:
Education:
" Bachelor s degree or equivalent combination of education, experience, and competencies.
Experience:
" 0-1 year of experience in pharmaceutical, medical device, or biotechnology experience, preferably in quality or regulatory affairs.
" 0-1 years of experience as a LMS Organization Administrator.
Preferred Skills/Qualifications:
" Certification as an administrator of a Learning Management System, or demonstrated equivalent experience and expertise, is preferred.
" Must be able to communicate via phone, computer and/or speaking.
Other Skills/Competencies:
" Familiarity with the regulatory requirements associated with training of personnel and training documentation (e.g., 21 CFR 820, 21 CFR 211, ISO 13485) is preferred.
" Effective interpersonal skills as well as written and verbal communication skills.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.