Senior Associate, Controlled Document Management

This position supports the Research and Development (R&D) organization and is responsible for assisting in the maintenance, management and retirement of controlled process documents, including the tracking of deviations related to such processes. 

Job Responsibility:

• Ability to navigate and work within an electronic document management system (EDMS). 

• Maintain and coordinate activities related to the EDMS including generating, revising and retiring R&D controlled process and operational documents. 

• Maintain the metadata associated with the aforementioned R&D controlled documents. 

• Ability to handle multiple assignments in a fast-paced environment with changing priorities. 

• Process incoming documents according to established document control procedures. 

• Maintain process related deviations in accordance with process requirements. 

• Prepare and review SOPs to ensure the submitted documents meet R&D controlled document quality standards. 

• Assure controlled documents are appropriately reviewed and approved prior to implementation via the change control process. Provide expertise and input to other functional areas related to R&D controlled documents. 

• Assist in the generation of metrics and reports related to the R&D process document control. 

• Support the periodic review of R&D controlled documents for compliance. 

• Assist in the preparation and coordination of requests from regulatory authorities and other compliance inspections/audits.