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Electronic Document Training Coordinator
5 months ago
(Onsite)
Provides documentation support for all operations, related to the SOP trainings and maintains all document related Training module (LMS) to ensure regulatory compliance in accordance to 21 CFR Part 820.25 (Personnel) and 21 CFR 211.100(a) (Written Procedures)
• Well Versed of LMS Software and LMS (Learning Management Software) Process.
• Manual Data entry of training records in to the LMS software.
• Uploading the Training Curriculum in the LMS software.
• Running training transcripts in the LMS software.
• Maintaining the training records department wise.
• Initiating the UAM's for the New LMS users.
• Assigning SOP's, global documents and courses, certifications in LMS to the Users.
• Creating / Modifying and maintaining the Job roles in the LMS software for department wise.
• Submitting monthly training reports to Corporate.
• Occasional Training on LMS to the new users.
• Maintain master binders for knowledge assessments.
• Adheres to written policies and procedures related to performing assigned tasks
Job Requirement:
• High School Diploma or GED required; Degree preferred
• Good Microsoft Office skills, including Word, Excel, and MS Access
• Working knowledge of Adobe Acrobat
• Must be detail oriented with the ability to multitask in a fast paced environment
• Effective verbal, written and interpersonal communication skills
• Team player with ability to collaborate with others
• Exhibits flexibility and professionalism when dealing with changing priorities and assignments
• Customer driven with sense of urgency/priority in responding to customers' needs (internal and external)
• Comprehension and awareness of the importance of achieving regulatory compliance
• Familiarity with an electronic data management system (EDMS)
• Working knowledge of documentation functions within a cGMP or ISO regulated environment
• 1-2 years of related experience (pharmaceutical/drug, FDA regulated and/or medical device industry) preferred
• Excellent verbal, written and interpersonal communication skills
• Excellent Microsoft Office skills, including Word, Excel, and PowerPoint
