Technical Writer – LMS Administrator

Role Overview

• The Technical Writer is responsible for the development, creation, and revision of controlled documentation using the OpenText System in accordance with Perrigo policies and procedures and current GMP practices.
• Partner with Quality department, other cross functional managers/supervisors, and engineers to ensure that controlled documents being revised contain the correct information.
• Provide support for maintaining the Learning Management System (LMS).
• Support/Train functional departments and subject matter experts in the creation and revision of cGMP documentation to optimize processing and ensure alignment with current practices utilizing the OpenText system: Standard Operating Procedures, Standard Work Instructions, Training Completion Statements, Job Aids, Controlled Forms.
• Execute tasks associated with LMS administration, including but not limited to the creation and maintenance of: creates and maintains GMP curricula, courses, and items.
• Enter training records in the LMS system or using the ATA system.
• Generate and track the audit of each curriculum working with department heads or curriculum owner.
• Provides training reports, training material and metrics as requested for compliance to support FDA audit, internal/external audit and miscellaneous requests.
• Recognizes and resolves training discrepancies, reaches out to Global training and communicates corrective action to affected personnel.
• Review cGMP documentation for standardized formatting, technical accuracy, clarity, grammar, and spelling.
• Select and edit images/videos (photographs, diagrams, technical drawings) to enhance training materials.
• Files all training documentation (hard copy) and provides general administrative support for the department as required.

Requirements

• Bachelor’s degree.
• 2 or more years of relevant systems experience required in a regulated industry, preferably in Life Sciences.
• Learning Management System (LMS).
• Understands the application of GMP concepts and understands 'why' behind the regulations.
• Possesses basic technical knowledge and background in the pharmaceutical and biotechnology industry.
• Comprehensive working knowledge of OpenText, Microsoft suite, including Outlook, Teams, Word, Excel, PowerPoint, SharePoint.