Document Control Manager jobs in United States
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Direct Relief · 10 hours ago

Document Control Manager

Direct Relief is a medical aid nonprofit dedicated to improving health and lives affected by poverty or emergencies. The Document Control Manager will oversee the document control program, manage the document review process, facilitate change requests, and support compliance programs while managing relationships with translation vendors.

AssociationCharityHealth CareHumanitarianMedicalNon Profit

Responsibilities

Oversee the document control program by supporting document creation, revision, and archiving processes
Manage the document module in the Quality Management System, including configuration, staff training, and reporting
Collaborate with teams to develop effective training programs, including training documents and effectiveness checks
Work closely with the Legal & Regulatory Affairs teams during the document publication process to ensure compliance with regulatory requirements
Develop and maintain new document control programs in support of Direct Relief’s regional growth
Develop and oversee the implementation of translation policies and processes, including translation vendor management

Qualification

Electronic quality management systemsFDA regulationsDocumentation PracticesMicrosoft WordMicrosoft ExcelMicrosoft VisioMicrosoft PowerPointSharePointERP systems (SAP)Employee training programsAnalytical skillsProblem-solving skillsVerbal communicationWritten communicationDetail oriented

Required

Knowledge of and experience in an FDA-regulated industry required with a sound understanding of Good Distribution Practices and Good Documentation Practices
Solid working experience in a position related to Quality Management Systems, including good understanding of requirements for documentation and training management in GxP environment
Good working business process knowledge of procurement, operations, warehousing, and order fulfillment
Bachelor's Degree
5+ Years of related experience
Proficient in working with Microsoft Word, Excel, Visio, PowerPoint, and SharePoint
General knowledge of electronic quality management systems, ERP systems (SAP preferred), computer-based management systems, and application of FDA regulations for applicable products preferred
Experience with system and process implementation
Strong system troubleshooting capability
Ability to apply Good Documentation Practices and regulatory requirements into user-friendly documentation and associated processes
Knowledge of best practices for employee training programs
Must have a collaborative work style
Must possess strong analytical and problem-solving skills
Must be a team player with strong verbal and written communication skills
Must have a commitment to high standards of professionalism and integrity
Must be patient and work with users to help them understand and learn concepts at a pace that matches individual skills
Ability to work independently with minimum supervision
Detail oriented with the ability to take initiative and work independently

Preferred

General knowledge of electronic quality management systems, ERP systems (SAP preferred), computer-based management systems, and application of FDA regulations for applicable products preferred

Company

Direct Relief

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Direct Relief is a humanitarian medical aid organization.

Funding

Current Stage
Growth Stage

Leadership Team

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Amy Weaver
Chief Executive Officer
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Craig Redmond
Chief Operating Officer
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Company data provided by crunchbase