Karen Overby
Manager Document Control @Cogent Biosciences
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WORK HISTORY
Manager Document Control @Cogent Biosciences
Responsible for the control, issuance, retainage, and archival of controlled documents and records.• Ensure periodic patches and upgrades to the EDMS are applied and validated.• Assist all departments in the generation of quality system documentation, such as, SOPs, CAPAs, deviation/investigation reports, change controls, and product complaints.• Implement and coordinate the training program to oversee creation of training plans, completion of required GxP and departmental training, evaluation of training processes, and identification and coordination of supplemental training• Provide Document Management and EDMS guidance and training• Generate and evaluate Quality metrics related to document and training management.• Initiate, assign, and ensure completion of workflows for review and approval or controlled documents.• Ensure quality and compliance of all controlled documents and records managed and maintained within quality management system.• Ensure the quality and timely processing of documentation within the EDMS.• Support regulatory audits and the internal audit program.• Actively engages in continuous improvement for areas of responsibility and collaborate with other departments to identify and implement process efficiencies.• Author / write and review SOPs / documentation.
EDUCATION
Regis University
Bachelor of Science in Business Administration (BSBA)
Regis University
Certificate: Executive Project Management
Regis University
Master’s Degree in Business Administration (MBA)
SKILLS
ABOUT KAREN OVERBY
Ensures the availability, control, and organization of the a company\'s key documents…
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