Document Control Manager Job Description
Document control manager
provides quality Assurance / Quality Control (QA/QC) audits of the hardcopy Document Control files and the Prolog electronic Document Control files.
Document Control Manager Duties & Responsibilities
To write an effective document control manager job description, begin by listing detailed duties, responsibilities and expectations. We have included document control manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Updating, maintaining and refining project document control procedures training other staff members on document control procedures
Handled administration and lifecycle management of procedural documents supporting business partner in the electronic document management system (EDMS, , truVAULT or equivalent)
Oversee the day-to-day operations of the Quality and Document Control group, ensuring the highest quality and compliance of all document management deliverables
Collaborate with other members of the Quality Management group, in support of the development and revision of procedural documents
Oversee the quality review and consistency checks applied across the department, ensuring accuracy and clarity of content within and across documents
Ensure the consistent use of the EDMS across the department
Handle resource planning across the procedural documents team and assignment of work to ensure documents are processed in a timely manner
Oversee all requests for procedural documents related to health authority inspections and internal audits
Ensure global coverage for responding to urgent requests in a timely manner
Provide support to the Janssen Pharmaceuticals Documentation Council for the administration and lifecycle management of cross-pharma procedural documents
Document Control Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Document Control Manager
List any licenses or certifications required by the position: DALF-C1, DELF-B2
Education for Document Control Manager
Typically a job would require a certain level of education.
Employers hiring for the document control manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Engineering, Business, Education, Science, Project Management, Technical, Manufacturing, Management, Construction Management, Biotechnology
Skills for Document Control Manager
Desired skills for document control manager include:
Prolog
Project controls procedures
Computer relational databases
Document control procedures
Excel spreadsheets
Expedition Contract Manager
Rail industry will be
Similar PIMS desired
AutoCAD
Database software
Desired experience for document control manager includes:
Collaborate with the relevant stakeholders to ensure generation, QC and approval of monthly procedural document data in support of the Pharmacovigilance System Master File (PSMF)
Oversee generation of routine reports
Maintain critical departmental tools, including the online request management tool, E2E Ownership Matrix, procedural documents tracker, deviations tracker, TOC, Develops metrics and reports in support of organizational and customer needs
Resolve issues related to the EDMS, specific documents and document management practices in general
Collaborate with the Quality Analytics team to ensure seamless and efficient handover and user-friendly templates that align with the EDMS requirements
Build personal network with other document management groups within Janssen R&D to share and leverage best practices and optimal use of the EDMS
Document Control Manager Examples
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Document Control Manager Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of document control manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for document control manager
- Keep abreast of latest developments in Procedural Document management
- Develop and implement document handling policies and procedures
- Act as a DCA for locations
- Manages and maintains all project plan room equipment, warranties and supplies
- Manage and implements Consortium Project Documentation Management Plan according to the rules defined in the Project Documentation Management Plan
- Build effective processes to ensure GxP Document Control is conducted in a timely manner and is accurately recorded
- Manage a Document Control team across UT sites
- Manage Document Change Control process (assignment, tracking, closure) to ensure adherence to regulatory requirements and current site practices
- Manage distribution of and access to approved documents and maintain controlled documentation
- Coordinate with appropriate departments to ensure all applicable documents are reviewed and revised with the specified review and revision timeframes
Qualifications for document control manager
- Minimum of 5+ years of document control experience
- Knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
- Demonstrated knowledge/subject matter expertise in GMP, SOPs and quality systems
- Works on multiple assignments in collaboration with various department system owners
- Advanced Skills with MS Office applications Word, Excel, Access, Adobe Acrobat
- Experience transitioning manual to electronic systems experience highly preferred
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Document Control Manager Job Description
Job Description Example
Our company is looking to fill the role of document control manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for document control manager
- Receive proposed draft documents from originators and perform initial review
- Circulate proposed documents for review, coordinating with all appropriate departments to ensure correct departments are involved in the review
- Conduct review of proposed documents prior to routing for approval
- Circulate final versions of proposed documents for approval, coordinating with all appropriate departments
- Create and manage document control log for consultants and contractors to ensure that proper documents are provided
- Plan, organize, and manage the activities of the QA Change Control and Document Control groups
- Establish performance goals and strategic/operational objectives for direct reports based on company and departmental goals
- Develop, define, and enforce departmental policies and practices
- Hire, train, develop and management performance of direct reports
- Establish effective communication and collaborative relationships with various functional groups and key stakeholders
Qualifications for document control manager
- Assist project leads in the processing of payment requests, change orders, submittals, and Requests for Information (RFIs)
- Assist leads manager with meeting minutes, project status update entries, and payment, change order, RFI, and submittal logs
- Maintain a project document filing system in accordance with procedures
- Prepare reports in accordance with procedures and forms
- Support all documents for all projects
- Enter and track following documents Submittals, RFI's, pending change order, change orders, and invoices that were reviewed and/or prepared by Cost Control Manager and Project Managers
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Document Control Manager Job Description
Job Description Example
Our company is growing rapidly and is looking for a document control manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for document control manager
- Lead cross-functional initiatives to completion
- Assist in the development, analysis, and management of the annual budget for internal and external resources and expenses
- May provide direction and technical assistance to other less experienced personnel
- Working with all functional areas of the company to prioritize and translate project requests and business needs into a coherent plan to evolve the Windchill PLM system at TEL FSI
- Implement solutions to improve company processes, data management, compliance, data access and data security
- Analyze and optimize the existing Windchill PLM system configuration/operation
- Manage projects to develop, test and rollout new functionality
- Develop process and procedures required for efficient use by all functional areas of the company
- Perform/coordinate upgrades to Engineering Systems software and hardware
- Provide technical expertise and advice to project teams and other support teams regarding engineering systems
Qualifications for document control manager
- University Degree and relevant industry experience
- Minimum of 2 years of construction management and or testing/inspection experience
- 5+ years of relevant pharmaceutical experience required
- Previous experience with regulated document control in a multi-site environment is required
- Travel to the Silver Spring office is generally required once per month
- Relevant experience with MasterControl is strongly preferred
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Document Control Manager Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of document control manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for document control manager
- Participate in cross-functional project teams for efficient project execution
- Set and meet project commitments
- Oversee the receipt, filing, and maintenance of all GXP documents, including but not limited to standard operating procedures (SOPs), test methods, specifications, incident reports, CAPAs, product complaints, computer system validation
- Design and implement an enterprise wide document repository that tracks the receipt, revisions, and archiving of all GXP documents
- Prepare any supportive process workflows and procedures for the new document repository to maintain efficiency and access for all users
- Function as the administrator for our Learning Management System (LMS)
- Maintain all users, curriculum, and training records within the LMS
- Responsible for the integration of the LMS with the enterprise document repository
- Creation and development of processes, archiving, and operations related to document control
- Lead and maintain corporate document management policies and procedures governing documentation, materials, Bills of Materials (BOMs), and data quality in SAP Enterprise Resource Planning (ERP) and SAP Product Lifecycle Management PLM) solutions
Qualifications for document control manager
- Experience managing direct reports strongly preferred
- Must be able to communicate effectively, both written and orally, with all levels of the organization
- Experience as a system owner and/or system administrator is preferred
- Familiarity with Document Management Systems and Learning Management System functionalities is required
- Experience with Electronic Document Management Systems (EDMS) preferred
- Strong computer skills including MS Office applications (Word, Excel, PowerPoint and Outlook) are required
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Document Control Manager Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of document control manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for document control manager
- Achieve and monitor document management performance results
- Ensure compliance with Federal, State and Local regulations pertaining to training, GMP/QSR, ISO9001/ISO13485/CMDR/CE and associated regulatory agencies through effective management of internal audit functions
- Manage Document Control Records Management and Processes
- Assist in establishing and conducting companionway training related to GMP/QSR and EU regulations pertaining to ISO13485/CMDR/CE
- Maintain and follow proper ISO procedures (ISO 13485 2003, ISO 14971 and GMP requirements pertaining to medical devices/IVDs)
- Assist to coordinate/manage training process
- Assist in activities relating to Regulatory Affairs (RA) with RA team
- Provide Quality Management Systems assistance for all facilities
- Assist to author, change and update Quality Manual and QA procedures as applicable
- Participate in project management/performance team meeting on behalf of the quality department in order to provide ideas, methods or processes for unit/company performance improvement
Qualifications for document control manager
- BS Degree in engineering, information sciences, computer science or related field or equivalent work experience
- Extensive experience with the new product development process, BOM management, Design change control process, configuration management and documentation control processes
- Extensive knowledge and experience of CAD, PDM, & CAE engineering systems, including PTC’s Windchill and Creo based application suites
- Knowledge of hardware infrastructure including engineering workstations, servers, and databases
- 3-5 years of experience with Microsoft Windows operating systems both client and server
- 1-3 years of experience working with Java, XML, HTML, JSP and UML concepts