Document Control Coordinator Resume Samples

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EB
E Bashirian
Eudora
Bashirian
271 Johnston Village
Boston
MA
+1 (555) 700 7866
271 Johnston Village
Boston
MA
Phone
p +1 (555) 700 7866
Experience Experience
New York, NY
Document Control Coordinator
New York, NY
Swift Group
New York, NY
Document Control Coordinator
  • Assist in the implementation, management and administration of the controlled document management system currently being SharePoint
  • Oversight of project specific construction management software, establishing protocols, work flow and verification
  • Manages the change workflow, which is the vehicle to execute the request for changes
  • Help to develop, implement and manage processes and procedures to assist all areas of the Group for Document Controls
  • Works with Project Management to perform project related tasks
  • Develops Document Management Plan issued to the client
  • Balances personal work and team priorities; maintains work-life balance
Los Angeles, CA
Field Document Control Coordinator
Los Angeles, CA
Bins, Hauck and Mohr
Los Angeles, CA
Field Document Control Coordinator
  • May provide guidance to managers regarding the disciplinary process
  • Assists Project Field Management with administering and communicating policies and procedures
  • May be responsible for providing administrative support for startup operations, engineering, project controls and/or procurement activities
  • Create and maintain a closely monitored secured location in which to store site documents
  • Supervises document control activities, including drawing control, project file management and use of electronic file storage system for project filing
  • Distributes new drawing revisions to all necessary parties (site engineers and superintendents)
  • Log, track, reproduce and distribute documents flowing in and out of the job site
present
Boston, MA
Quality Document Control Coordinator
Boston, MA
Langworth, Casper and Kunze
present
Boston, MA
Quality Document Control Coordinator
present
  • Write, revise, and develop Quality related forms and Standard Operating Procedures
  • Work with Quality Management to prepare Certificate of Analyses for Williamson produced products
  • Review all incoming ingredient Certificate of Analysis (COA) documents, to assure supplier compliance with critical factors, as prescribed in respective specifications. Identify deviations for follow up with Suppliers and/or Procurement. Maintain Certificate of Analysis file
  • Work with Quality Technicians, relating to the monitoring, completion of, and documentation of calibrations (per calibration schedule), for all laboratory testing equipment in the plant, which used to verify product conformance to specification and also to critical control point limits
  • Maintain and file all Food Safety/HACCP related CCP records; assist with record review. Sign/authorize, as delegated by Quality Management. Maintain and control HACCP deviation files, and work with Quality Management to assure corrective action. Track CCP validations against schedule
  • Serve as a plant GMP and VMS auditor
  • Coordinate and maintain Food Safety and Quality System related documents within the prescribed and approved Document Control Process and Procedure. Maintain document control files, logs, records, shared drive entries, and hard copy manuals outside of the QDL, to assure all documents are current, properly identified, and maintained
Education Education
Bachelor’s Degree in Building Science
Bachelor’s Degree in Building Science
Arizona State University
Bachelor’s Degree in Building Science
Skills Skills
  • Demonstrated knowledge of basic mathematics, including the ability to add, subtract, multiply and divide all units of measure
  • Knowledgeable in use of computers and applicable software (SAP, Word, Excel, PowerPoint, Outlook)
  • Knowledge and participation in regulatory or quality system audits
  • Able to work with accuracy and attention to detail
  • Demonstrate ability to attention to detail
  • This will include working in the Document Management environment to create new change orders, populate necessary information, and work with engineering staff to attach necessary documentation, route to approvers per local approval matrices, pursue approvals as a surrogate for engineers, and execute all activities related to change orders until closure
  • Excellent personal interaction skills; outgoing, confident, and strong personal presentation. Self-starter, willing to learn, seeks out opportunities for career and personal development
  • Knowledgeable of Microsoft office products
  • Excellent verbal and written communication skills, able to work well within a consultative team-oriented environment. Seeks and welcomes support, feedback, and input from others
  • Ability to read and proof read documents for correct grammar and spelling, strong multitasking and prioritization skills, notation & documentation skills, ability to work unsupervised
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15 Document Control Coordinator resume templates

1

Document Control Coordinator Resume Examples & Samples

  • Assist in the implementation, management and administration of the controlled document management system currently being SharePoint
  • Review and approve documents for consistency of format and systems compliance
  • Assist in management of archival activities with controlled documents and validation files (electronic media)
  • Maintain all off-site and on-site records management to include a monthly reporting of records eligible for destruction
  • Maintain IMDS compliance of all parts at Drive Automotive
  • Do internal or external audits as needed per Sr. Management. Assist with customer audits when required
  • Administration support for the Quality Department
  • Participate in the LPA process
  • Download automated inspection Perceptron data
  • Build and maintain “Turtles” utilizing data gathered via Perceptron or DataMytes and transmit to specified customers
  • Automate and prepare PIST reports for all customers. Maintain programs and procedures for PIST reporting
  • Implement and maintain programs for SPC data gathering devices except on CMM and Perceptron
  • Initiate training on methods and SPC gathering devices except on CMM and Perceptron
  • Initiate and maintain SPC charting and ensure data input
  • Help ensure SPC equipment are stored in a safe, clean and orderly condition
  • Enforce customer quality expectations with respect to quality standards and deviations
  • 3+ years experience in a document control environment preferred
  • Advanced knowledge of Microsoft products including Excel, SharePoint, Word and PowerPoint
  • Understanding of ISO and TS16949 concepts and guidelines
  • Understanding of IMDS and environmental reporting system
  • Basic knowledge of Applied Stats or equivalent SPC data management system
  • Strong communication, prioritization and organizational skills
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers and general public
  • Associate Degree preferred
2

Document Control Coordinator Resume Examples & Samples

  • Minimum 1 year of Food Safety, Quality and Regulatory and/or EH&S experience
  • Basic Auditing/compliance-Applies basic auditing and quality compliance skills to identify and manage risks/compliance
  • Good written and verbal communication abilities
  • Demonstrates organizational skills
  • Knowledge and experience with safety programs
  • Excellent computer skills (word processing, spreadsheets, and database navigation)
  • Ability to train employees and infuence change
  • Ability to collaborate and communicate effectively with remote team members
3

Document Control Coordinator Resume Examples & Samples

  • Works independently on new and on-going assignments
  • Identifies and solves problems using established business rules and procedures
  • Continuous improvement minded
  • Comfortable with ambiguity and change
  • IND-LSG
4

Quality Document Control Coordinator Resume Examples & Samples

  • Min 2 years experience in the pharmaceutical/biopharmaceutical industry (e.g. GxP, pharmaceutical production document control)
  • Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable
  • Participate in department optimization efforts; take the lead on selected projects and assignments, following them through to closure
  • Update departmental Standard Operating Procedures as needed
  • Prepare and route documentation packages throughout review and approval cycle
  • Track document approval activities in electronic tracking system; ensuring on-line e-library is updated and accurate
  • Distribute approved documentation to appropriate personnel, track receipt of documentation, and maintain distribution matrices
  • Initiate and track periodic Documentation Binder Audits to assure documentation in the field is current and complete
  • Issue controlled Production Documentation to Manufacturing and Laboratory Notebooks to cross functional areas; maintain records of issuance
  • Label and code files for storage in on-site Documentation Centers
  • Ensure ethics and compliance commitment at all times. Report/Address compliance issues in a timely manner. Attend cGMP training programs as required
  • BA/BS degree or equivalent experience is preferred
5

Document Control Coordinator Resume Examples & Samples

  • Experience in Microsoft Office and database management (Excel, Word, Power Point, Access)
  • Strong organizational skills, planning and follow through on projects / tasks
  • Requires analytical thinking and presentation of ideas / results
  • Results and success driven; demonstrates integrity
  • Excellent time management skills (prioritizing and follow-up)
  • Ability to deliver high-quality, error-free work that is exact and complete by paying close attention to detail
  • Capable of sitting for extended periods of time creating certifications
  • Ability to maintain an organized approach to managing daily activities while juggling multiple demands
  • Ability to scan and electronically index files and documents including creating methodologies for organizing and retrieving those documents
  • Manually files records, type, photocopy and distribute departmental documents
  • Must possess flexibility in working after hours or on weekends, as project needs and shipment schedules dictate
  • Must exhibit excellent judgment by considering all pertinent factors, making decisions quickly and carefully, and accepting responsibility for the decisions
  • Must be a self-starter, alert for situations requiring action, confident of being able to think situations through, and possess the ability to work independently with minimal supervision
  • Must be able to maintain a high activity level and be able to effectively manage and prioritize numerous projects and responsibilities
  • Establish/maintain procedures for maintaining documents and change control of documents. Evaluate and develop improved techniques for the control of documents
  • Directly responsible for maintenance of the company document control system, reporting on the performance of the document control system for review and as a basis for improvement
6

Document Control Coordinator Resume Examples & Samples

  • Responsible to initiate, review, route, and implement change of documents (procedures, work instructions, forms, and specifications, and other related product documents)
  • Responsible for updating logs for change requests and engineering control, linking them to completed documentation
  • Recommends content and format changes to internal customers, as needed, to ensure compliance to Document Control requirements
  • Responsible for tracking of document change requests and training requirements associated with change request in compliance with training procedure, and document status notifications
  • Responsible for supporting Management Review with metrics data on change requests and Quality Documents and support timely document search and delivery during audits
  • Supports other QA processes, such as QMS training, Non Conformance, Audits, Corrective Action, Preventive Action, Continual improvement
  • Works with internal department staff and management to ensure implementation of uniform practices in accordance with the principles of quality and good documentation practice
  • Responsible for ensuring security and accuracy of all Quality Documents, including formatting, processing, and scanning and saving to shared computer servers
  • Associate Degree in a Scientific (preferred) or business field
  • 2 years experience with document control process. Previous work in an ISO environment, preferred
  • Ability to perform a wide range of tasks relating to Document Control, including computer word processing with Word, Excel, PowerPoint; creating and manipulation of Excel spreadsheets
  • Excellent organization skills, attention to detail and accuracy
  • Self-motivated multi-tasker who works effectively and continuously improves the QMS in fast-paced environment
  • Good communication skills and interpersonal skills with customer-oriented focus
  • Fast learner with ability to clarify areas of ambiguity
7

Document Control Coordinator Resume Examples & Samples

  • Must have developed analytical and problem solving skills
  • Knowledgeable of Microsoft office products
  • Oral and written communications skills necessary
  • Must be detail oriented and have a general understanding of corporate business systems
  • Must be able to work independently with assigned task
  • Ability to investigate, perform preliminary testing and present findings
  • Enter alpha/numeric data from source documents on computer, using a PC and following formatted display on screen
  • Must be flexible with data entry instructions, as procedures can change frequently
  • Compare data entered with source documents
  • Advise management of recurring problems
  • Identify system problems and report to management
  • Display a commitment to error-free and highly productive work
8

Document Control Coordinator Resume Examples & Samples

  • Works with team to improve the web based and internal document system and correct discrepancies
  • Helps research software and systems that may benefit the department and company, providing detailed findings
  • Maintain electronic processes for the intranet SharePoint site, and for documents placed within the external internet site
  • Create roll-out plan with department(s) for implementation of documentation; also create and maintain various databases throughout department
  • Establish and maintain security rights for all corporate and subsidiary users within Active Directory
  • Maintain document release and revision histories as well as master document list
  • Identify the needs and goals of the organization and of the quality system
  • Review content for use in web-based environment
  • Establish and maintain electronic sites and locations within internal and external web-based environment
  • Administer and maintain the web-based system, and plan for system maintenance
  • Supports the establishment of effective formats and layouts to create documents and edit documents to assure compliance with established format and content standards
  • Write and edit clear and concise documents regarding quality systems
  • Maintain the quality record-keeping system in accordance with internal and external requirements
  • Coordinates status of released documentation and quality systems, such as open/overdue corrective actions, active testing, closure reports, deviations, and product qualification approvals
  • Helps plan, schedule, and audit organizational systems and procedures
  • Report audit discrepancies and provide follow-up with open action items and formal corrective action requests
  • Schedule document reviews with various department personnel
  • Introduce quality system standards through presentations
  • Work closely with I.T. to ensure electronic systems are running efficiently and effectively
  • Generate and issue reports based on customer requests
  • Proficient computer skills with intermediate to advanced knowledge of various desktop software applications including: InfoPath, SharePoint, K2 – Process management flow software, Adobe Acrobat Writer, PhotoShop, Active Directory, , Remedy, Visio, PowerPoint, and Snag-It
  • Adept with various types of filing systems
  • Detail-oriented with the ability to work under pressure to meet critical deadlines
  • Able to adapt to new priorities based on changes in business or production support demands
  • May work extended hours in critical situations
  • Able to work with peers in a manner that fosters teamwork
  • Excellent communication skills including the ability to express technical and non-technical issues verbally and in writing
  • Demonstrated knowledge of basic mathematics, including the ability to add, subtract, multiply and divide all units of measure
  • Ability to read and comprehend technical information and documents such as safety rules, operation and maintenance instructions, procedure manuals, and work documents
  • Demonstrate excellent attention to detail
  • Excellent organizational skills, with logical approach to establishing and maintaining records
  • Able to work independently and adapt quickly and appropriately to a fast-paced environment
  • Able to conduct research utilizing various methods and skills
  • High School diploma required. Associates degree or equivalent education/experience preferred
  • Minimum 2 years experience in a documentation systems management role
9

Document Control Coordinator Resume Examples & Samples

  • Provides support to the technical service teams in support of technical data integrity and entry. Support includes completion of tasks associated with coordination of Configuration Control
  • Processes Document Control Request/Notices (DCRN) and Engineering Change Orders (ECO)
  • Processes and releases Customer Change Requests (CCR) and Manufacturing Change Orders (MCO)
  • Assists with part classification for export control
  • Conducts various additional tasks for the Drafting team
  • Creates and updates procedures and guidelines associated with the various technical services/configuration control processes and tools
  • Works with Engineering to ensure data and documentation is valid and accurate for the various processes
  • Sends communicative emails on status reports (ECOs/DCRNs completed for day.)
  • Perform other duties as required and available for overtime
  • Ensures quality product utilizing UTAS quality procedures
  • Audits work area for safety compliance
  • Adheres to all UTAS rules and code of conduct
  • Minimum 1-3 years of Document Control experience required (depending on level of education)
  • Team Center and SAP (or other Engineering documentation database and MRP system) experience required
  • Familiarity with Product Lifecycle Management (PLM) and/or Enterprise Resource Planning (ERP) systems
  • Familiarity with Engineering Change Orders and Customer Change Requests required
  • Strong proficiency with Microsoft Office products including Excel, Word, and PowerPoint required
  • Ability to write, edit, and proofread business correspondence, proposals, procedural manuals, and other written material
  • Must have a high level of organization and ability to multi task within several independent efforts
  • Excellent interpersonal communication skills, both written and oral, with the ability to interact with all levels of the Company
  • Requires the ability to exercise independent judgment required
  • Time management and problem solving skills including the ability to consistently meet deadlines
  • Demonstrated ability to maintain confidentiality
  • Demonstrated ability to attention to detail
10

Document Control Coordinator Resume Examples & Samples

  • Determines and develops approaches to documentation control assignments and processes
  • Responsible for quality documentation projects and/ or processes which require use of planning and judgment
  • Solves a broad range of problems of varying scope and complexity
  • May require some higher education or specialized training/certification
  • Minimum of 3 years of document control experience, typically 6-8 years
  • Knowledge of document control requirements and procedures in a manufacturing environment
  • Ability to multi-task and troubleshoot
  • Knowledgeable in use of computers and applicable software (SAP, Word, Excel, PowerPoint, Outlook)
  • Excellent Attention to detail
  • Data entry skills
  • Demonstrated ability to work with cross functional team members and technical professionals
  • Experience in an ISO 13485, FDA regulated or cGMP-compliant environment
  • Experience in the Medical Device industry
  • Experience writing Standard Operating Procedures
  • Experience with technical writing
  • Knowledge and participation in regulatory or quality system audits
11

Document Control Coordinator Resume Examples & Samples

  • Processes approved documents and maintains current versions of all controlled documents
  • Responsible for ensuring all documents are in the correct format
  • Ensures all controlled documents are reviewed as required
  • Maintains numbering system of procedures, manuals and project forms as well as distribution lists
  • Distributes controlled copies of procedures and manuals
  • Receives requests for publications from departments, checks applicability of publication and orders when needed; distributes received publications to applicable departments
  • Must possess and continuously maintain a current driver’s license
  • Work requires long, strenuous hours under pressure and extensive interaction with customers
  • Must be willing to work overtime as required and cross train as directed
  • Must comply with published Company work rules
  • Will be required to work an uncommon tour of duty including nights, week-ends and holidays
  • Must be able to pass a Pre-employment drug test and a National Agency Check with Inquiries (NACI) for computer access
12

Field Document Control Coordinator Resume Examples & Samples

  • Supervises administrative support functions and staff as needed, including receptionist, and document control clerk. Supervisory duties include coordination of day-to-day activities, addressing performance issues, and recommending pay actions
  • Supervises document control activities, including drawing control, project file management and use of electronic file storage system for project filing
  • Log, track, reproduce and distribute documents flowing in and out of the job site
  • 1+ years relevant experience required. Some related open shop and/or union experience preferred
  • Human Resources and PeopleSoft experience
  • Some related open shop and/or union experience required
  • Knowledge of administrative policies and procedures
  • Knowledge of expense reporting policies and procedures
  • Knowledge of electronic file storage system
  • Accounting skills
  • Customer & Employee Relation skills
  • Oral and written communications skills
  • Multi-tasking ability (prioritize, organize, schedule work)
  • Office equipment troubleshooting skills
  • Desktop PC (Outlook, Access, Excel, Word)
13

Document Control Coordinator Resume Examples & Samples

  • Responsible to Initiate, review, route, and implement change of documents (procedures, work instructions, forms, and specifications, and other related product documents)
  • Responsible for tracking of document change requests, and training requirements associated with change request in compliance with training procedure, and document status notifications
  • Responsible for supporting Management Review with metrics data on change requests and Quality Documents; and support timely document search and delivery during audits
  • Other administrative duties as assigned by supervisor
  • 2 years of experience with document control processes
  • Previous work in an medical device/IVD environment
  • Excellent organization skills, attention to detail and accuracy, self-motivated multi-tasker who works effectively and continuously improves the QMS in fast-paced environment
  • Associate's Degree in a scientific or business field preferred
14

Document Control Coordinator Resume Examples & Samples

  • Excellent communication and computer skills
  • Proficient in database management, specifically SAP PM, QM and BOM processes
  • Proficient in Engineering change management system, such as Windchill
15

Document Control Coordinator Resume Examples & Samples

  • Implements and maintains document repositories and archives
  • Coordinates review and revision of controlled documents
  • Issues and maintains master manufacturing documentation and supporting documentation
  • Coordinates document requests and stages documents for presentation during regulatory inspections
  • Provides guidance to user departments in proper use of document change systems to ensure consistency of system usage
  • Maintains departmental databases
  • Degree qualified preferred, with 1-2 years relevant work experience to support responsibilities of position. Additional related work experience will be substituted for educational requirement
16

Document Control Coordinator Resume Examples & Samples

  • Maintain procedures for maintaining documents and change control of documents
  • Determine and enforce through functional groups document control requirements in order for the company to meet internal and external needs
  • Collect and maintain files of the latest documentation revision level necessary to control manufacturing processes
  • Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution
  • Maintain a computer database of all filed documentation that ensures fast retrieval of documents
  • Perform clerical duties to generate documents as necessary
  • Perform duties as defined in division document control policies and procedures
  • High school diploma or equivalent education and work experience, preferably in a field that offers and opportunity to gain a well rounded background
  • Additional training in documentation control (i.e., courses/seminars in Document Change Control)
  • The Director of Regulatory and Human Resources Manager can determine whether education and training are “equivalent”
  • Proficient in Microsoft Word, Excel, PowerPoint, Outlook and Sharepoint
17

Document Control Coordinator Resume Examples & Samples

  • Bill of Material Maintenance: Lead the management of accurate and timely entry of Engineering Change Orders from our customers using Agile PLM on a daily basis ensuring clear and concise descriptions and reasons for the change and disposition of components no longer needed. Approval tracking is necessary to ensure a timely release and distribution of the change to the customer team to ensure proper data is available to generate material requirements and support the manufacturing process. Verification of Plexus bill of material to the customer bill of material is done to ensure bill of material integrity resulting in customer satisfaction. Update to work order data in JD Edwards based on approved Engineering Change Orders is required for proper component usage when necessary
  • Chance Requests: Lead the entry, approval management of deviations/waivers and problem advisories as received by external and/or internal customers to ensure accurate material requirements and manufacturing processes as they arise
  • Customer Service: Actively listen and respond to the needs of customer team members, actively participate as a member of the customer team to support external customer satisfaction. Contribute to customer team success by providing leadership in the customer data package, utilizing strong communication skills to ensure optimal effectiveness for the customer team
  • Plexus manufacturing operations knowledge
  • Agile or other PDM software
  • Advanced problem solving skills
  • Ability to manage fluctuating workloads, schedules and deadlines
  • A minimum of an Associate's degree or equivalent experience is required for this position; an Associate's degree is preferred
  • A minimum of 2 years of experience in a Document Control position is required for this position, assuming education requirements are met. Equivalent industry experience of 1 or more years is highly desirable
18

Document Control Coordinator Resume Examples & Samples

  • Generates and revises documentation as required utilizing the appropriate software application such as; Word, Excel, AutoCAD etc
  • Routes and tracks the status of R&D Documentation and ensures in­-process and final document status (e.g. released, filed)
  • Reviews R&D documentation for accuracy and completeness prior to release and filing
  • Ensures correct revisions of documentation, where applicable, are located in the laboratory areas and applicable files
  • Negotiates with associated parties such that action taken on/completion of documents in assured in a timely fashion
  • Maintains the designated Document Control filing locations (e.g. Archives) and retrieves files from storage as needed
  • Remains abreast of record retention policies required by the company and required for regulatory compliance
  • Fulfills the responsibility as Change Administrator II when required to do so as defined by the PLM Corporate Standards and the facilities Quality System Procedures. This pertains to procedures, work instructions and op. sheets, etc
  • Participatse in software validations as required
  • Assists with the facility Training matrix. Also maintain the facilities shared network drive for released, revised and archive documentation by coordinating with document originators
  • Maintains the calibration system database. Provide or design reports using Crystal Report software as necessary for data sets relating to the facility within Calman
  • Assists with scheduling and organizing R&D Management Review meeting, takes meeting notes for transcription and subsequent distribution, tracking follow-­up actions and filing
  • Serves as a resource during internal & external audits
  • Associate of Applied Science (A.A.S.) degree in biological, chemical, mechanical, electrical, or electronic technology, plus a minimum of five years engineering test function
  • PC literacy, including word processing and spreadsheet skills required
  • Minimum of 2­ to 5 years experience in Laboratory, Engineering or Manufacturing environment required
  • Must be proficient in computer skills including but not limited to Microsoft applications, CDA, Oracle and the system
  • Ability to use office equipment such as laptops, projectors, faxes, copy machines
  • Familiarity with FDA and International Standards & Regulations
  • Ability to work well with individuals from dispersed functional areas across internal and external organizations
  • Ability to plan and conduct effective meetings
  • Ability to assist in writing reports, business correspondence, meeting minutes & procedures
  • Ability to read and proof read documents for correct grammar and spelling, strong multitasking and prioritization skills, notation & documentation skills, ability to work unsupervised
19

Project & Document Control Coordinator Resume Examples & Samples

  • Benchmark and evaluate existing document control practices, identify gaps and make improvements. Assist to develop and implement document control processes, procedures, requirements and change controls for Document Owners to meet internal and external compliance requirements. Respond to all inquiries (legal, audit…etc) regarding Document Controls. Communicate all new or updated Document Controls to relevant users Assist and create, develop and present PowerPoint and/or other types of presentations to management as requested (live, Webcast, etc.). Generate reports on the performance of Document Controls projects for appropriate management. Help to develop and conduct training programs and guidelines for all users of utilized document control systems (MS SharePoint and FileNet). Conduct workshops as needed. Along with manager and document owners, develop roll-out strategy for communications/change management where required for new or updated documentation. Support staff as needed and directed, outside vendors, consultants and contractors Help to identify and manage requirements for staff Help to develop and track budget effectiveness/efficiency involving all document controls programs (systems, creation for all projects - all vendors/contractors, IT costs, etc.). Be knowledgeable of corporate Procurement requirements and procedures and ensure they are implemented and adhered to
  • Engineering documentation knowledge
  • Ability to interact with engineers and project personnel on technical matter
  • Must have a valid drivers license
  • Must demonstrate and value differences in others' strengths, perspectives, approaches, and personal choices
  • Utility engineering project or document control experience
  • Knowledge of FileNet or Documentum systems a plus
20

Document Control Coordinator Resume Examples & Samples

  • Responsible for the Document Control function and ensures that the various document control standards and procedures are followed
  • Records and tracks internal and external distribution of documents
  • Ensures the timely transfer of electronic files to/from engineering consultants, project team, construction team, and contractors/vendors
  • Responsible for data entry and maintenance of internal and external databases
  • Prepares transmittals, scans and files documents, and performs other clerical tasks
  • Responsible for the assignment and control of drawings, new drawing numbers, equipment, instrumentation and line numbers
  • Ensures that all required fields of information on request forms and drawings have been entered correctly
  • Monitors and ensures that engineering processes are being followed
  • Responsible for adhering to all health and safety policies and guidelines
  • Performs other duties or assumes additional responsibilities as required
  • Intermediate computer skills in Word / Excel. Experience with databases an asset
  • Able to multi-task and manage a heavy and varied workload
  • Excellent verbal and written communication skills, able to work well within a consultative team-oriented environment. Seeks and welcomes support, feedback, and input from others
  • Excellent personal interaction skills; outgoing, confident, and strong personal presentation. Self-starter, willing to learn, seeks out opportunities for career and personal development
  • Receives direction and instructions on new assignments from management team, however is expected to operate independently within a sphere of responsibility
  • Makes decisions on individual work flow, recommends changes to existing processes, and develops drafts for onward approval as required
  • Must be able to capable of decision-making within defined role and displays strong initiative
  • Minimum of 1 year experience working in an administrative support position or equivalent
  • Experience working in an engineering environment an asset
21

Document Control Coordinator Resume Examples & Samples

  • Maintenance of the project document management platform (Infinitrac)
  • Responsible for processing of all submittals and input into Infinitrac
  • Generate submittal logs, RFI logs, and various document control reports
  • Receive, log, and track plans and specifications as received including all revisions
  • Distribute plans and specifications to contractor personnel, subcontractors and designers
  • Maintain all hard copy files of project documentation
  • Maintain electronic copy files of project documentation
  • Process and maintain files for change order requests, change orders, contracts, scope changes, and payment applications in an orderly and updated manner
  • Process and maintain transmittals and associated documents
  • Track and file project photos
  • Work with superintendents, engineers, and administration as required
  • Work with client’s and designer’s representatives as required
  • Other miscellaneous duties to support engineering department
  • Support Project Manager, Construction Manager, Superintendents, and Construction Engineers in regards to submittals, RFI’s, drawings, specifications, and other project documents
22

Document Control Coordinator Resume Examples & Samples

  • Responsible for project managing the process of change control
  • Support the coordination, preparation and implementation of controlled materials/documents via Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs) and Engineering Change requests (ECRs)
  • Update BOMs, Item Master and Item Branch as requested
  • With internal customer to collect product related information
  • Manages the change workflow, which is the vehicle to execute the request for changes
  • Maintains accurate records of all in-process Engineering Change Orders (ECOs)
  • Provides end-users status updates on their requests
  • Executing product data changes for approved changes orders in JDEdward (Oracle ERP) or SAP as appropriate
  • Respond to internal customer inquiries, train end-users and troubleshoot issues as necessary
  • Responsible for all changes related to sku discontinuation
  • Initiate Master Data updates as necessary, ensuring completion of corrections
  • Will take part in mass data updates in Agile and ERP systems as necessary
  • Provide raining for new team members
  • May be required to perform other related duties as required and/or assigned
23

Document Control Coordinator Resume Examples & Samples

  • Copy, prepare and mail a variety of department information/packets
  • Prepare and mail a variety of letters and forms
  • Assist in timekeeping duties
  • Assist in document preparation
  • Is able to identify priorities and manage them to achieve results
  • Have excellent organizational skills. Being able to manage multiple files simultaneously. Manages personal work space materials in a responsible and organized way
  • Balances personal work and team priorities; maintains work-life balance
  • Manages requests in a professional and timely manner
  • The Administrative is expected to be familiar with the company’s safety program and enforce the safety policy always. Never walk past an unsafe act
  • Receive, Distribute, and File Documents Posted
  • Update Logs
  • Post documents in our DCC system
  • Issue Daily Reports
  • Manage the Filing Systems
  • Audit Controlled Documents
  • Check logs for accuracy
  • Audit Work Pack Documents
  • Monitor the flow of Subcontractor Submittals
24

Document Control Coordinator Resume Examples & Samples

  • Coordinate document control process
  • Responsible for quality of the project materials and documents to issue for construction
  • Responsible for set-up for medium-sized projects
  • Analyzes data for error identification and reporting
  • Leads coordination of documents for medium project
  • Communicate with clients and vendors on a daily basis
  • Troubleshooting client and vendor issues
  • Develops Document Management Plan issued to the client
  • Responds and resolves any issues for vendors and clients having difficulties with document management system
  • Assists in developing and facilitating training programs, classes, and procedures for department
  • Responsible for updating segments of processes and procedures and communicating/evaluating effectiveness
  • Works with Project Management to perform project related tasks
  • Compiles subcontract documents and issues appropriate revisions
25

Document Control Coordinator Resume Examples & Samples

  • Receiving all information related to the project and distributing the information to the responsible parties
  • Maintaining a register of all project documents by way of continuous updates of related logs tracking all incoming and outgoing documents
  • Management and monitoring of timelines related to submissions or review process by way of email notification and reminders
  • Interfacing with the Project Team on Document Control matters and training all applicable project staff in the use of the document management system
  • Scanning, filing, photocopying, report preparation and drafting of letters and correspondence
  • Ensure all project documentation is compliant with project formats, company standards, styles, and verification forms
  • Organize final reports and submissions for delivery and prepare courier packages
  • Experience in Administration and/or document control services environment will be an asset
  • Familiarity with handling drawings and technical documents will be an asset
  • A self-starter with strong organizational skills and the ability to take initiative
  • Strong computer skills, including Word and Excel skills
  • Team player with a flexible attitude and the ability to prioritize workload and handle multiple tasks/deadlines
  • Integrity, professionalism and excellent communication and interpersonal skills that are required to handle both internal and external communications with tact and diplomacy
  • Available for occasional overtime work; and
  • Strong verbal and written communication skills in both French and English is an asset
26

Document Control Coordinator Resume Examples & Samples

  • Administrative tasks: spreadsheet maintenance, report preparation and presentation
  • Review and maintenance of specification revisions
  • Update of revisions in company ERP system
  • Other tasks in support of QA Engineers/QA Manager
  • Maintenance of approved supplier register including issuance of desktop audits
  • Maintenance of SharePoint documentation (includes procedures and forms related to the Quality Management System)
  • Distribution of Quality System documentation for training purposes
  • Archive maintenance of Quality System documentation
27

Document Control Coordinator Resume Examples & Samples

  • Follow SOP’s to meet compliance requirements for all document and QA activities
  • Administer and manage the electronic controlled document management systems, including management of Quality Records, Design History Files, Engineering Change Orders, Design History Record reviews, and Batch/Raw material Release
  • QA Final product lot release activities including executed batch records and raw material
  • QA review of label documentation, verifies printed sample labels for correctness
  • Manages the archiving process and inventory listings for on-site and offsite, including purchase orders records
  • Process changes through the Change Control, ECO, and Document change process
  • Review document changes and provide effective communications of changes for site awareness and to facilitate training requirements and provide applicable site training
  • Administer and maintain compliant periodic review scheduling and reporting
  • Administer and maintain records and number issuance for equipment and log notebooks
  • Serves as in-house expert on creation and closure of change controls
  • Supporting the training program for Siemens Molecular Diagnostics as required
  • Strategize within Quality and cross-departmentally to assess effectiveness of current document control processes and make recommendations for improvements
  • Develop metrics and reports
  • Quality Document Control QA Subject Matter Expert (SME) before, during, and after inspections and audits
  • Serve as the quality operational technical representative on any teams evaluating new documentation processes or systems
  • Administer system updates to the document control system as required
  • As the SME participate and collaborate with Business Units/departments to ensure QMS compliance and alignment of local SOP’s as required with common Business Unit SOP’s
  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient
  • Science or related degree preferred
  • 3+ years’ experience in Quality roles
  • Electronic document management system control/administration and/or management experience, ideally in the role of system owner in a Medical Device Industry
  • Strong technical writing skills
  • Advanced software skills (including SharePoint, Acrobat Pro, Microsoft office – work, excel,), and demonstrated troubleshooting and problem-solving techniques
  • Proven ability to work under tight deadlines and pressure in a composed manner
  • Comfortable communicating with all levels of staff, including executives
  • On site management of the document control functions with the ability to travel as business would require
  • Working knowledge of US / EU regulations and guidelines, including 21 CFR Parts 803, 820, ISO 13485, IVDD, and audits
  • Familiar with SAP and SharePoint
  • Project management or leadership skills
  • Ability to develop and present training materials to large groups, author and update controlled document procedures as needed
  • Experience with Lotus Notes Document Change
  • 1-2 years training system implementation and control/administration or system owner
  • Strong SAP experience and Trackwise
  • Experience as a team or lead ISO auditor within the medical device industry
28

Document Control Coordinator Resume Examples & Samples

  • Work with internal and external representatives to create/confirm filing system/organization and manage project files
  • Receive, log, track and file engineering documentation, drawings, and document files, including change logs and revisions histories to meet internal and customer requirements
  • Manage distribution and communication of updated drawings to appropriate personnel through both automated and manual processes
  • Work with customer and internal personnel to determine and enforce document control requirements to ensure the company meets internal and external document control policies
  • Implement and enforce communication protocols and distribution matrices for project documentations, work with project managers, engineers, customer representatives, and other project participants to ensure adherence to protocols and procedures
  • Consult with engineers and designers to resolve discrepancies and compile required changes to documents. Post changes to computer or manual control records, release documents, and notify affected departments
  • Evaluate and develop improved techniques for the control of documents. Recommend improvements to both existing document control processes and the development of new processes, including, but not limited to, managing concurrent engineering release levels and version control
  • Use Microsoft Word and Excel to create document control documents such as transmittal letters for drawing approval and Submittal Document Index
  • Review, maintain and close job files for shipped jobs
  • Perform handling of documentation via sources including FedEx, DHL, and other 3rd party courier services
  • At least three years of experience receiving, logging, tracking, and filing engineering documents, engineering drawing and document files within a document control department
  • At least three years of experience working with a computer-based document filing system such as an FTP (File Transfer Protocol) network
  • At least one year of familiarity with BOMs (Bill of Materials) and MTRs (Mill Test Reports)
  • At least three years of experience with Microsoft Office Suite (Word, Excel, PowerPoint)
  • At least one year experience working with Microsoft Project
29

Document Control Coordinator Resume Examples & Samples

  • Process documentation changes. Create change control documents and follow approval in Document Control Systems, Kintana and D2
  • Create requisitions and route documents for approval
  • Route and follow up with approvers of CER, protocols and reports
  • Support engineers to make travel arrangements and create expense reports
  • Provide administrative support of project and process engineers
30

Document Control Coordinator Resume Examples & Samples

  • Requires strong personal computer skills, advanced experience with Microsoft Office Applications (Excel and Word)
  • Some knowledge of FDA Good Manufacturing Practices/Quality System Regulations and ISO Standards required
  • In depth knowledge of electronic document control systems with Master Control experience strongly preferred
  • Basic Oracle experience strongly preferred
  • Must be able to work as a team member, maintaining day to day activities while being responsive to changing priorities
  • Must be detailed oriented, be able to follow detailed instructions, possess excellent time management skills, and be well organized
31

Document Control Coordinator Resume Examples & Samples

  • This will include working in the Document Management environment to create new change orders, populate necessary information, and work with engineering staff to attach necessary documentation, route to approvers per local approval matrices, pursue approvals as a surrogate for engineers, and execute all activities related to change orders until closure
  • Excellent skills with various software and document management tools
  • MS Word, MS Excel, and Adobe Acrobat are essential to this role
  • Excellent organization and time management skills, as completion of work will be time-bounded and requested from multiple sources, sometimes simultaneously
  • As the team supported by the PLM Coordinator is dispersed globally, excellent communication skills are a must
  • Maintains central, controlled supply of classified and unclassified documents originating within an organization. Reviews documents to determine pre-established classification level based on contracts or security manual, distribution requirements and processes distribution requests according to established procedures
  • Ensures generation of quality assurance checklist for product release packages in support of production schedules. May be required to maintain a secure, computerized document revision system, a periodic review system, and status tracking for all process-related documents and records
32

Document Control Coordinator Resume Examples & Samples

  • Provides support to Engineering and Manufacturing through data integrity and entry. Support includes completion of tasks associated with coordination of Documentation Control
  • Processes Engineering Change Orders (ECO) and Document Control Request/Notices (DCRN)
  • Creates and updates procedures and guidelines associated with the various technical services/documentation control processes and tools
  • Adheres to all UTAS rules and codes of conduct
  • Works in a fast-paced office/manufacturing environment with moderate noise levels
  • Must wear PPE (Personal Protection Equipment) in required areas
  • Prolonged sitting required
  • Ability to input, retrieve, access, and send accurate information via computer
  • Team Center (or other Product Lifecycle Management – PLM) experience required
  • SAP (or other MRP system) familiarity required
  • Familiarity with Enterprise Resource Planning (ERP) systems
  • Demonstrate ability to maintain confidentiality
  • Demonstrate ability to attention to detail
  • Understanding Bill of Material (BOM) structures preferred
  • Ability to multi-task conflicting priorities in a high-pressure environment while maintaining a customer-oriented demeanor
  • Ability to apply logical thinking to practical problems
33

Document Control Coordinator Resume Examples & Samples

  • Organize and review launched change requests (CR) in Bard EDMS, to include verification of completeness, accuracy, and the documentation is formatted correctly
  • Perform functions and responsibilities of Bard EDMS System Administrator, e.g. configuration of system, user management, report creation, user training, etc
  • Process and monitor external division documents in accordance with BPV and Corporate procedures
  • Responsible for the timely distribution of documents and the removal of obsolete documents to users/departments that are on official distribution
  • Coordinate and support the document review, external document review, corporate document review, and processes to include maintenance of department databases
  • Understand and follow compliance requirements, including the ability to interact with internal/external customers, auditors, and other professionals
  • Accurately maintain all documents controlled by the department utilizing the necessary methods and databases
  • Perform clerical duties, i.e. typing, filing, data entry, etc
  • Support department responsibilities/tasks via cross training
34

Document Control Coordinator Resume Examples & Samples

  • Handles the document flow within the environment and monitors where general correspondence is at all times as it relates to bid documents, drawings, binders etc
  • Responsible for establishing and maintaining a filing system for storage and retrieval of documents
  • Responsible for the coordination and distribution of all bid documents, drawings, binders etc
  • Confer with department supervisors or other personnel to assess progress and discuss needed changes
  • Examine documents, materials, or products and monitor work processes to assess completeness, accuracy, and conformance to standards and specifications
  • Requisition and maintain inventories of materials or supplies necessary to meet production demands
  • Document and drawing control as it relates to receiving new and/or revised drawings. The issuing of new and/or revised drawings
  • Other duties as assigned by department manager
  • Associates degree in Building Science, Construction Management, or an Engineering discipline
  • Minimum of three years related experience
  • Ability to accurately maintain files
  • Ability to use office equipment such as copier, fax machine, and scanner
  • The successful candidate will have exceptional written and verbal communication skills, as well as organizational and interpersonal skills
  • Computer literate with working knowledge of Microsoft Office (including Outlook, Word, and Excel) and other construction industry related software
  • Bachelor’s degree in Building Science, Construction Management, or an Engineering discipline
  • Valid driver license
35

Document Control Coordinator / Administrator Resume Examples & Samples

  • Reviews site change requests and change orders for compliance to procedures, formats and content
  • Processes change requests and change orders at each phase, ensuring correct approvals are obtained and all comments are addressed
  • Conducts employee training on change order process and procedures, including AGILE training and system access
  • Develops and publishes metrics supporting the document control system, and summarizes in reports as needed
  • Develops and implements document and AGILE system improvements in the form of continuous improvement projects and compliance initiatives
  • Participates in validation of the AGILE system for use by the site
  • Participates in quality system improvement projects and assists in compliance gap remediation as needed
  • Support and actively participate in internal audit program
  • Extensive knowledge of ISO 13485, FDA CFR 820, CMDR standards and regulations
  • Demonstrated ability to work effectively and positively with all levels of an organization
  • Capable of working both independently and in a team setting; team oriented and committed to continuous improvement
  • Proficient skills with Microsoft Office (Word, Excel, PowerPoint)
36

Document Control Coordinator Resume Examples & Samples

  • Work with Director of Construction, Project Team, and Project Administrative Manager as directed to achieve departmental and project objectives. The work will flow as required by the day to day requirements of the project
  • Support the creation and of all project information and documentation such as RFP’s, Contracts, Purchase orders, Flow charts, Quality Assurance plan, Change orders, submittals, requisitions, meeting minutes, specifications, schedules, punch lists, notices to proceed, stop work orders etc
  • Document control paper and digital including document flow, distribution process, file system etc
  • Oversight of project specific construction management software, establishing protocols, work flow and verification
  • Maintain status reports, action and task lists as directed
  • Follow up with the design, engineering, and construction management teams as directed
  • Update project schedules with scheduling manager
  • Support requisition approval process, quantity and material verification as directed
  • Assist Quality Assurance manager as required, punch lists, status reports, commissioning reports, etc
  • Maintain and track project information as required
  • Perform special projects of a highly skilled nature
37

Quality Document Control Coordinator Resume Examples & Samples

  • Coordinate and maintain Food Safety and Quality System related documents within the prescribed and approved Document Control Process and Procedure. Maintain document control files, logs, records, shared drive entries, and hard copy manuals outside of the QDL, to assure all documents are current, properly identified, and maintained
  • Maintain and file all Food Safety/HACCP related CCP records; assist with record review. Sign/authorize, as delegated by Quality Management. Maintain and control HACCP deviation files, and work with Quality Management to assure corrective action. Track CCP validations against schedule
  • Review all incoming ingredient Certificate of Analysis (COA) documents, to assure supplier compliance with critical factors, as prescribed in respective specifications. Identify deviations for follow up with Suppliers and/or Procurement. Maintain Certificate of Analysis file
  • Work with Quality Technicians, relating to the monitoring, completion of, and documentation of calibrations (per calibration schedule), for all laboratory testing equipment in the plant, which used to verify product conformance to specification and also to critical control point limits
  • Review weight control data, to determine the establishment of appropriate weight control limits; provide monthly cost of overfill
  • Work with Quality Management to prepare Certificate of Analyses for Williamson produced products
  • Serve as a plant GMP and VMS auditor
  • Write, revise, and develop Quality related forms and Standard Operating Procedures
  • Participate in special projects, as determined and delegated by Quality Management
  • Provide training as applicable
  • Able to multi task and work independently
  • High school diploma or general equivalency diploma (GED) with 3 years of technical writing experience OR an Associate’s of Science degree
  • 3 years of experience with Microsoft Office to include Word, Excel, PowerPoint, and Access
  • Prior clerical experience with quality document control support
38

Document Control Coordinator Resume Examples & Samples

  • Contributes to the overall operations and to the achievement of departmental goals
  • Maintains MasterControl document system, including completing document control activities and system administrative duties
  • Maintains the External Document program
  • Acts as the designated Archivist with regard to maintaining accountability and control (storage and retrieval) of quality records, data, and/or SOPs
  • Coordination of off-site document storage
  • Responds to client document requests
  • Performs support functions for client audits
  • Performs maintenance of applicable data bases / spreadsheets of quality data
  • Complete additional Quality Departmental tasks as requested
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures, where ability to recognize deviation from accepted practice is required
  • Interact effectively with Operations, Testing, and Quality Department personnel in order to deliver superior customer service
  • Works under supervision from supervisor or senior personnel
  • Associate or Bachelor degree or equivalent experience
  • 1-2 years of QA experience in a regulated or ISO industry
  • Proficient in electronic document control system MasterControl required
  • Must have strong attention to detail and ability to maintain focus
  • Must be diligent, organized, and dependable
  • Good working knowledge of pertinent internal SOPs
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in computer programs (e.g., Microsoft office)
  • Must be able to work in an office environment with minimal noise condition
  • Perform sedentary work
  • May be required to work holidays and weekends
  • May be required to work overtime
  • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices, including Good Documentation Practices
39

Document Control Coordinator Resume Examples & Samples

  • Help to develop, implement and manage processes and procedures to assist all areas of the Group for Document Controls
  • Create a change management plan to implement/roll out Document Controls Plan Assist to enforce document control requirements and rules for standards Perform system administration tasks if and when required Work with QA procedures to test and evaluate the system Help to develop processes to help ensure archiving of regulatory documents in a central repository and required access and distribution as needed Required
  • Excel and file management skills
  • Must foster an inclusive work environment and respects all aspects of diversity
  • Knowledge of MOSS SharePoint 2007- ability to work with Web Parts (A plus, not required)
  • Knowledge of McLaren, EMC Documentum Software, FileNet, desired. Similar systems and software experience also strongly considered
  • Advanced knowledge of excel
40

Document Control Coordinator Resume Examples & Samples

  • Review production and laboratory records for completeness and accuracy in accordance with company and regulatory requirements
  • Provide finished product releases based on DFA and state regulatory review findings
  • File and maintain batch production and control records
  • Inform management of food safety management system conformance to Safe Quality Foods (SQF) standards through key performance indicators and trend reporting
  • Maintain employee training records and conduct internal reviews
  • Collaborate with leadership when non-compliance issues are found. Ensure that supervisors fully explain and document production deviations
  • Document and update SOP's for facility
  • Administer plant SOP program through release to departments that are affected, maintain plant master SOP binder, verify operating department SOP training documentation, and ensure SOP training is documented annually for all employees
  • Process hold and disposition system based on leadership instructions. Verify dispositions are carried out and holds are properly documented
  • Support administrative and quality related studies as assigned by leadership
  • Dedicate effort to safety as we expect every employee to leave work in the same condition as they arrive
  • Follow all DFA good manufacturing practices (GMP) and work in a manner consistent with all corporate regulatory, food safety, quality and sanitation requirements
  • Exhibit the values and ethics of Dairy Farmers of America through honesty, discretion and sound judgment
  • Adhere to all DFA Quality, Safety and GMP policies and procedures and report any nonconformity
  • Attend required training, including but not limited to Safety, GMP, Hazard Analysis and Critical Control Point (HACCP) and SQF
  • The requirements herein are intended to describe the general nature and level of work performed by employee; but is not a complete list of responsibilities, duties and skills required. Other duties may be assigned as required
  • Certification and/or License
  • Knowledge of Microsoft Office Suite and company computer systems, specifically SAP
  • Knowledge of regulatory requirements (GMP, PMO, USDA, OSHA, and HACCP)
  • Skill in proficient computer usage
  • Able to communicate clearly and effectively, both verbally and in writing
  • Able to take initiative in performing job and seek increased responsibilities
  • Able to adapt and manage change effectively
  • Able to work with accuracy and attention to detail
  • Able to work in collaboration effectively and foster good teamwork
  • Able to follow directions and meet deadlines
  • Able to interpret and apply company policies
  • Able to perform task and duties without constant supervision
  • Able to read, write and speak English