Senior Associate, Controlled Document Management

Senior Associate, Controlled Document ManagementThis 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.Qualifications:B.S. degree required

Minimum three (3) years' experience in a regulated industry

Knowledgeable in FDA expectations is preferred

Direct experience in GXP compliant quality systems is preferred

Excellent document processing skills including: document quality review, typing and PC skills (MS Word, Excel, PowerPoint, Adobe Acrobat, etc.).Excellent communication skills including: customer service, ability to influence, negotiate, and conflict management skills.Must work effectively and independently in a team environment and with individuals at all levels within an organization.Additional necessary characteristics include: being a self-starter, goal oriented, attention to detail, and ability to multi-task.With Regards,Kavita KumariClinical RecruiterIntegrated Resources, IncInc. 5000 – 2007-2014 (8th Year)Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70