Job Summary: 

• Engage change owner to ensure document changes include required information, such as change rationale, relevant documentation, and appropriate implementation strategies.
• Review, process, and ensure changes are processed following established procedures.
• Process the change requests on documents such as procedures, work instructions, component specifications, document changes, etc.
• Monitor changes throughout the document lifecycle to ensure accurate and speedy processing.
• Provide support to cross-functional teams in projects.
• Provides quality assurance support and review of documents change activities to operations.
• Ensure completeness of document control processing activities to meet requirements as per approved procedure and work instructions.
• Review the correctness of document content and formatting before releasing the document.
• Review the approval list to ensure the sufficiency of approvers from different functional areas based on the approval matrix.
• Guide and support the record owners with questions and queries.

Skills on Resume:

• Document Management (Hard Skills)
• Change Control (Hard Skills)
• Quality Assurance (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Process Optimization (Hard Skills)
• Attention to Detail (Soft Skills)
• Compliance and Regulatory Knowledge (Hard Skills)
• Problem Solving (Soft Skills) 

Job Summary: 

• Take responsibility for definition, Implementation, and execution of project procedures for document and engineering data management.
• Control, distribute, consolidate, and maintain internal and external document deliverables.
• Definition, setup, and execution of engineering data management procedures per internal and/or customer requirement
• Coordinate with key internal functional groups to communicate critical project information such as the status of electronic review cycles and document schedules
• Perform Quality Checks on engineering and supplier deliverables (document number, title, revision, date, etc.) and comply with company and project requirements.
• Execute project document and data management activities in global workshare amongst Linde Engineering entities in Germany, India, etc.
• Compile final documentation (paper version and/or electronic version)
• Create, review, and revise documentation procedures according to Integrated Management System (IMS)
• Organize and maintain documents, adhering to the company's document lifecycle procedures, and archive inactive records following the records retention schedule
• Learn and abide by the Linde Code of Ethics and Code of Conduct.

Skills on Resume: 

• Document and Data Management (Hard Skills)
• Project Management (Hard Skills)
• Quality Control (Hard Skills)
• Cross-Functional Coordination (Soft Skills)
• Compliance Management (Hard Skills)
• Global Workshare Management (Hard Skills)
• Documentation Procedure Development (Hard Skills)
• Ethics and Conduct Adherence (Soft Skills)

Job Summary: 

• Maintain a document management system compliant with GMP Quality Systems, ICHQ10, and NKGen Biotech requirements.
• Responsible for the management of all lot documentation and records issuance processes to support clinical and commercial manufacturing.
• Responsible for the routing, review, approval, distribution, and archival of new and revised controlled documents.
• Manage the creation, review, and revision of SOPs and training documentation for the document control department.
• Provide guidance and advice on approved procedures, standardization, and requirements associated with the lot document management system.
• Responsible for enhancing and maintaining the document change control system for batch record issuance and label issuance.
• Collaborate with cross-functional departments to ensure timely implementation of changes to the batch record and label issuance system.
• Print, compile, and issue all lot-related documentation (batch records, labels, sample plans, specifications, etc.)
• Investigate deviations against the lot documentation and records issuance system and develop effective corrective action plans.
• Develop or enhance training content for batch record and label issuance processes and procedures.
• Provides training to new staff on batch record and label issuance processes and procedures.
• Be the quality record owner (deviations, CAPA, CC) associated with batch record and label issuance processes and procedures.

Skills on Resume:

• Document Management Systems (Hard Skills)
• GMP Compliance (Hard Skills)
• Batch Record Management (Hard Skills)
• SOP Development (Hard Skills)
• Change Control Management (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Training and Development (Soft Skills)
• Corrective Action Planning (Hard Skills) 

Job Summary: 

• Create, update, and release drawings procedures and travelers to support manufacturing.
• Assign and enter numbers in PLM for new products, documents, drawings, and schematics.
• Responsible for entering and processing new component forms.
• Analyze and process Change Orders and Deviations utilizing the internal system.
• Monitor Change Order and Deviation approval/implementation and be able to assist in resolving issues.
• Verify data completeness and compliance with policies and procedures
• Verify technical documentation to ensure correct numbering, formatting, revisioning, checking, and approving compliance with policies and procedures.
• Reproduce and distribute technical documentation.
• Assist in cataloging and controlling technical documentation
• Retrieve documentation for users, and ensure proper upkeep of technical documents
• Promote own professional development
• Manage label creation, print, schedule, and delivery to manufacturing, and maintain label stock materials safety stock.
• Perform basic maintenance and troubleshoot label printing equipment.

Skills on Resume:

• Document Control (Hard Skills)
• PLM Systems (Hard Skills)
• Change Order Management (Hard Skills)
• Technical Documentation Review (Hard Skills)
• Data Verification and Compliance (Hard Skills)
• Label Management (Hard Skills)
• Equipment Maintenance and Troubleshooting (Hard Skills)
• Professional Development (Soft Skills) 

Job Summary: 

• Responsible for the coordination of Documentation and Data input for NA Quality document conversion to a new company template
• Assure compliance with company Quality Management Systems policy and ISO standards for document control
• Verify documentation accuracy to ensure a compliant record for future audits
• Update or develop appropriate training materials to ensure ongoing compliance
• Provide virtual training to stakeholders on any updated training material
• Collaborate with various individuals and cross-functional team members to mitigate any system issues or process concerns
• Actively participate and coordinate various tasks related to document control migration to the new document control system
• Identify/locate physical records against the master inventory spreadsheet
• Add physical records to file boxes and create a file box manifest
• Scan records to verify completeness as a true copy, and upload a true copy to the electronic document management system
• Ensure the master inventory spreadsheet is updated daily to reflect record inventory and delivery status
• Process records identified for offsite storage at Iron Mountain
• Use an electronic records management system (Veeva) to update record metadata

Skills on Resume:

• Document Control (Hard Skills)
• ISO Standards Compliance (Hard Skills)
• Training Development (Soft Skills)
• Virtual Training Delivery (Soft Skills)
• Cross-Functional Collaboration (Soft Skills)
• Document Management System (Hard Skills)
• Records Inventory Management (Hard Skills)
• Electronic Records Management (Hard Skills) 

Job Summary: 

• Bring the AOS, Quality Systems, and Policies into compliance and certification with ISO9001 quality system requirements
• Maintain and enhance the Documented Information Systems (such as Giganet and Solidworks PDM)
• Assist Business Process owners in the maintenance of archives of required documents and records
• Directly interfaces with department leadership to investigate and resolve documented information issues
• Lead document audits to ensure only controlled and proper revision-level documents are in use across the Array
• Participates in internal quality audits, reviews, verifies, and maintains quality records
• Coordinates and assists with external audits, ensures timely completion of tasks in the QMS
• Facilitates continual improvement of processes and procedures with all departments (i.e. Quality, Engineering, Manufacturing, Field Service, Supply Chain, Contracts, etc)
• Assists in the planning of Management Review meetings
• Assists in the preparation of the agenda, records minutes to distribute and file
• Assists in reviewing manufacturing, maintenance, safety, and quality control documents, files, reports, lists, etc.
• Effectively communicates and reports initiatives, deficiencies, and results to the management team
• Participates in or conducts Documented Information training

Skills on Resume:

• ISO9001 Compliance (Hard Skills)
• Document Management (Hard Skills)
• Quality Audits (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Process Improvement (Soft Skills)
• Audit Coordination (Hard Skills)
• Meeting Documentation (Soft Skills)
• Training (Soft Skills) 

Job Summary: 

• Serve as a point of contact to facilitate the exchange of information with customers, vendors, and other interested parties
• Complete documentation requests from customers concerning quality and regulatory compliance
• Assist with the preparation and maintenance of internal technical documentation
• Develop and maintain knowledge of the internal food safety management scheme (FSSC22000)
• Review incoming documentation for compliance with internal standards and procedures
• Organize and maintain compliance documentation files
• Track and ensure supplier approval documentation remains up-to-date
• Enter data into the internal enterprise resource management system
• Support documentation and regulatory functions of Quality, Purchasing, and Sales departments
• Follow established procedures to prepare and format client audit and tax documents
• Review document language and format to ensure quality output following compliance procedures
• Proof, edit, and format financial statements and other reports for final review and approval, complete and send to client and/or tax agencies on behalf of clients
• Prepare electronic copies of drafts, as well as print and collate draft copies for client meetings in a professional format when needed
• Convert documents, when necessary, from multiple formats
• Work independently to manage workflow and volume of requests using tracking software

Skills on Resume:

• Communication (Soft Skills)
• Documentation Management (Hard Skills)
• Food Safety Knowledge (Hard Skills)
• Compliance Review (Hard Skills)
• Data Entry (Hard Skills)
• Proofreading (Hard Skills)
• Report Prep (Hard Skills)
• Workflow Management (Soft Skills) 

Job Summary: 

• Maintain the integrity of the engineering item master database, engineering drawings, curriculum documents, and software files.
• Use independent critical judgment, evaluate non-standard problems, and recommend actions for their resolution.
• Coordinate Product Change Orders and provide assorted services to support a smooth transition between engineering and all other departments.
• Create and maintain Item Master records and Bills of Materials in MFG Pro (QAD) and manage relevant files, including AVLs, electromechanical drawings, software, and procedures and manuals.
• Maintain item master data at 99.5% or better accuracy rate to ensure the integrity of the database.
• Maintain relevant original and PDF files at current revision to support procurement and manufacturing operations.
• Work in collaboration with CAD designers to process Hold Orders, Product Change Requests (PCRs), and Product Change Orders (PCOs) following the established workflow.
• Investigate a variety of document-related problems and identify solutions.
• Maintain a log to record any temporary changes to the item master.
• Distribute relevant PCO documentation to functional groups.
• Work with purchasing to provide the latest revision of documents and Bills of Materials to suppliers via FTP and email.
• Maintain warranty, and export compliance inventory site data at the item level.
• Work closely with Engineering, IT, Finance, Customer Service, Procurement, and Manufacturing to develop IT and workflow processes to manage business accurately and efficiently.
• Perform all tasks following ISO 9001 quality requirements.

Skills on Resume:

• Database Management (Hard Skills)
• Problem Solving (Soft Skills)
• Product Change Coordination (Hard Skills)
• Item Master Management (Hard Skills)
• Data Accuracy (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Document Management (Hard Skills)
• ISO 9001 Compliance (Hard Skills) 

Job Summary: 

• Coordinate the activities of Document Control, including the tracking, release, distribution, and auditing of controlled documents, maintenance of electronic department directories, and tracking and reporting on document review progress.
• Manage archival activities for controlled documents.
• Organize and facilitate approval process of Change Control Orders (DCO), and Engineering Change Orders (ECO), including distribution and archiving of final documents whether hard copy or electronic.
• Collaborate with subject matter experts on technical subjects positively to prepare controlled documents that conform to a defined format.
• Review and proofread documents for consistency of document format and system concerns.
• Use department software to track, manage, and control issued documents, and assign identification numbers.
• Assign training timely and accurately according to the appropriate training matrix.
• Effectively follow SOPs, policies, and FDA Good Manufacturing Practices.
• Provide support for the Quality Systems and Regulatory departments during internal and external audits and actively participate in department activities.
• Trend documentation activities relating to employee training to support compliance requirements.
• Support the internal audit program and external audits.
• Support the CAPA program

Skills on Resume:

• Document Control Management (Hard Skills)
• Change Control Coordination (Hard Skills)
• Technical Document Preparation (Hard Skills)
• Document Review and Proofreading (Hard Skills)
• Software Management (Hard Skills)
• Training Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Audit Support (Soft Skills) 

Job Summary: 

• Accountable for the Document Control function at the Raleigh site and a portion of the Woodcliff Lake site.
• Act as subject matter expert for Eisai’s electronic document management system (eDMS).
• Control documents throughout the lifecycle, training and assisting system users, reviewing, approving, and executing system change control and validation documentation, and identifying and resolving compliance issues.
• Partners with other document control functions within Eisai to deliver the eDMS platform to other locations.
• Facilitate off-site storage and retrieval of departmental records.
• Assist with creating and revising departmental record retention schedules.
• Perform internal audits of documents and records and manage the periodic review process.
• Exercises judgment in cooperation with Quality Systems management to oversee and manage controlled document processes for the Raleigh site and several WCL departments.
• Control over 700 documents for at least 18 departments.
• Provide support and system training for users at five sites.
• Business owner (point of contact) and subject matter expert for eDMS (Controlled Documents)
• Review and approve eDMS change control and validation documentation in cooperation with QS management
• Control documents and provide end-user support and training for eDMS
• Provide records management support to Raleigh Quality Operations
• Perform internal document and record audits, and manage periodic review process.

Skills on Resume:

• Document Control (Hard Skills)
• eDMS Management (Hard Skills)
• Compliance Resolution (Hard Skills)
• Cross-Site Collaboration (Soft Skills)
• Record Retention (Hard Skills)
• Internal Audits (Hard Skills)
• Training Support (Soft Skills)
• Change Control (Hard Skills) 

Job Summary: 

• As a member of the Orascoptic Research and Development team
• Responsible for creating and maintaining design and quality documentation
• Support product development, manufacturing, quality assurance, and continuous improvement of best-in-class electromechanical and optical products
• Create, maintain, and standardize the documentation to support the production of electromechanical medical devices
• Prepare and drive Engineering Change Orders (ECOs) through the completion
• Take responsibility for controlling part number issuance
• Create and maintain product family tree structures
• Maintain Design History Files (DHF’s) and Device Master Records (DMR’s)
• Support international product registration by compiling documentation as requested by Regulatory Affairs (RA)
• Design, draft, and manage manufacturing tool drawings
• Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO 13485 regulatory requirements
• Plan and coordinate all CCB meetings for drawing releases, ECOs, and design kick-offs/release reviews.
• Store all documents and maintain control of them in Terrafugia's archive system - detail drawings, BOMs, parts lists, wire lists, assembly drawings, procedures, test plans and reports, and manuals.
• Maintain control of all “document managed” items (e.g., regulatory, company, and customer requirements, specifications, etc.) that may be not revision controlled but need to be retained.
• Properly set up the database/folders and servers for ease of access, with limiting control (read-only and read/write access privileges).
• Create training slides for the Document Control Processes, and train staff on the use of the Document Control System.

Skills on Resume:

• Design Documentation (Hard Skills)
• Product Development Support (Hard Skills)
• Engineering Change Order Management (Hard Skills)
• Part Number Control (Hard Skills)
• Regulatory Documentation (Hard Skills)
• Compliance Assurance (Hard Skills)
• Document Control Management (Hard Skills)
• Staff Training (Soft Skills) 

Job Summary: 

• Manage document workflows in Thermo Fisher Scientific’s electronic document management system ensuring documents go through the controlled document life cycle following established procedures.
• Ensure documents meet formatting and template requirements, and adhere to required review and approval requirements and project timelines.
• Manage GMP documentation tracking, reconciliation, and archiving
• Manage high-density file room inventory, filing, and scanning.
• Manage offsite document archival with approved vendors
• Perform GMP document and label issuance
• Perform documentation coordinator activities in eDMS and work with departments on documentation needs.
• Provide site training on document workflow modules
• Author or revise standard operating procedures related to document control
• Provide documentation support during client audits and regulatory inspections.
• Assists with the improvement of quality compliance by recognizing continuing issues and bringing them to management’s attention
• Subject Matter Expert (SME) in the assigned scope of controlled document lifecycle and records management process
• Communicates internally, inter-organizationally, and with cross-site document management contacts frequently
• Maintains quality system program requirements, e.g., record retention and destruction, legal hold
• Support compilation of department metrics and report out to management.
• Coordinate collection and compilation of slides for management review meetings such as QMR and Quality Council
• Generate and report out meeting minutes for routine QS meetings such as deviation review board, change control review board, and CAPA review board

Skills on Resume:

• Document Workflow Management (Hard Skills)
• GMP Documentation Management (Hard Skills)
• Archiving and Inventory Management (Hard Skills)
• Document Issuance (Hard Skills)
• SOP Development (Hard Skills)
• Audit Support (Soft Skills)
• Communication and Collaboration (Soft Skills)
• Meeting Coordination (Soft Skills)