Knowledge Management Operation Specialists

Operating within the Global Quality Compliance & Systems organization, supporting Global Quality and Regulatory Affair (GQRA), the Knowledge Management (KM) Operations Specialist supports the Knowledge Manager Operations organization. The KM Operations Specialist is responsible for supporting QMS document changes, training curriculum management (including assignments), audit and inspection support, and ensuring site-level compliance with Documentation and Training Management activities.

Key responsibilities include:

• Support the creation, implementation, and measuring effectiveness of QMS documents and training programs.

• Partner with GQRA and functional stakeholders to support audits and inspections via collection of impacted qualification records and QMS documents.

• Support the implementation of updated Quality Management System (QMS) documents (e.g. SOPs, Work Instructions, etc.).

• Provide support for global, and local, audits and inspections by providing employee qualification records, retrieving effective documents from the Documentation Management System (DMS), and addressing identified gaps in our global Documentation and Training Management materials.

• Support company-wide or Global Quality & Regulatory Affairs programs and strategic projects focused on improved documentation and training systems.

• Pull training performance metrics, KPIs, and other performance indicators to assess the health of the Knowledge Management system.

• Support global training management systems initiatives (DMS and LMS) locally.

• Bachelor's or Master's Degree or equivalent

• 3+ years' of administrator experience supporting a Documentation Management System (DMS) and/or Learning Management System (LMS) in a regulated environment is helpful

• Experience working for a pharmaceutical, medical device, or other regulated organization is preferred

• Experience using MS Office Suite (Outlook, Word, Excel, PowerPoint, Edge) is preferred

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