Document Control Specialist Resume Samples

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K Bayer

Katelynn

Bayer

99397 Gleason Corner

Philadelphia

+1 (555) 792 5368

99397 Gleason Corner

Philadelphia

Phone

p +1 (555) 792 5368

Experience Experience

Boston, MA

Document Control Specialist

Boston, MA

Swift-Swift

Boston, MA

Document Control Specialist

Configure document management system features to document workflow procedures. Create and maintain document approval matrixes
Initiate and manage product listings for selected product lines, working closely with product managers, technology, marketing and sales
Follow standardized work practices and procedures, working with product managers marketing, packaging and other product listing resources
Manages the change workflow, which is the vehicle to execute the request for changes
Working in Illustrator or In Design to check artwork layers, packaging links, fonts and documents together
Manages Document Control SystemManages, stores, transmits and monitors flow of documents involving vendors, Architect Engineers and Covanta project teams
Maintains and manages document management systems (DvTDM), including troubleshooting, upgrades, testing, training team members, and coordination with IT

San Francisco, CA

Sheffield Document Control Specialist

San Francisco, CA

Rippin-Leffler

San Francisco, CA

Sheffield Document Control Specialist

Work daily queues for titles that are missing and call dealers with questions on missing titles
File UCC 1 and UCC 3 in CT Lien solutions. Review daily UCC file for exception management
Assist dealers and clients with issues regarding the liens and other legal documents related to the titles
Mail “Paid in full” letters and credit balance refunds along with corresponding titles, Manufactures Statement of Origin (MSO) or other documents to the customer
Work daily in VINTEK to obtain account information for titles that have been received via e-filing
Coordinate the scanning of the titles via Filenet
Pull titles, MSO's, UCC for payoffs, charge offs or repossessed accounts

present

Detroit, MI

Document Control Specialist, Irwindale, CA

Detroit, MI

Zemlak, Reynolds and Stracke

present

Detroit, MI

Document Control Specialist, Irwindale, CA

present

Assist Documentation Supervisor with improvement and standardization of Document Change Control processes
Assists customers in coordinating engineering change orders
Develop engineering change orders packages
Excellent time management
Knowledge of software system dependencies and data management
Support NDP pipeline projects
Enters engineering data into cPDM

Education Education

Bachelor’s Degree in Accuracy

University of Pittsburgh

Bachelor’s Degree in Accuracy

Skills Skills

Ability to manage time well, multitask and troubleshoots with strong attention to detail
Ability to lift up to 50 lbs. and have a strong attention to detail
Highly detail-oriented
Excellent interpersonal and communication skills and the ability to work with all levels throughout the organization
Ability to handle high-pressure situations in a professional and effective manner
Strong attention to detail
Ability to manage several tasks at once with the knowledge and experience to effectively prioritize
Working knowledge of applicable regulations, such as cGMP
Detail oriented with good organizational skills
Basic knowledge of office machinery such as copier and scanner

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15 Document Control Specialist resume templates

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Document Control Specialist Resume Examples & Samples

Understanding of risk and regulatory requirements of the role
Some knowledge of departmental systems and applications
Basic investigation skills
Basic customer service skills
Good sorting and organizational skills

Sheffield Document Control Specialist Resume Examples & Samples

Enter titles in Sheffield loan servicing system and file titles in the safe
Coordinate the scanning of the titles via Filenet
File UCC 1 and UCC 3 in CT Lien solutions. Review daily UCC file for exception management
Mail “Paid in full” letters and credit balance refunds along with corresponding titles, Manufactures Statement of Origin (MSO) or other documents to the customer
Pull titles, MSO's, UCC for payoffs, charge offs or repossessed accounts
Work daily queues for titles that are missing and call dealers with questions on missing titles
Process daily mail consisting of titles. Code loan servicing system as needed as titles are released or titles are received
Work daily in VINTEK to obtain account information for titles that have been received via e-filing
Prepare and send Letters of Guarantee to insurance companies if a customer has wrecked or totaled the financed equipment
Send titles back to Department of Motor Vehicles (DMV) or dealers to have mistakes corrected
Assist dealers and clients with issues regarding the liens and other legal documents related to the titles
Two years of title or lien perfection experience
Demonstrated knowledge in banking or financial services
Demonstrated proficiency in basic computer applications such as MS Office
Bachelors degree in Business

Document Control Specialist Resume Examples & Samples

Documents specifications for new or proposed content management systems
Prepares document management policies to ensure compliance to regulatory requirements
Administers document system access and revision control to ensure appropriate security based on business need. Ensures document processing replication, distribution and storage access levels are maintained
Assists with the assessment, acquisition and/or deployment of electronic document management systems. Writes, reviews and/or executes plans for testing new ot established document management systems
Conducts needs assessments to identify document requirements for end users
Assists in the development of document classifications to facilitate information storage and retrieval. Ensures proper classification based on security level, function and other criteria
Configure document management system features to document workflow procedures. Create and maintain document approval matrixes
Documents and maintains standards, best practices and other requirements for system document management system usage
Implements electronic document processing, retrieval and distribution systems in collaboration with other information technology systems
Monitors regulatory activity to maintain compliance with regulatory agency requirements
Prepares, records and manages changes to documents. Confirms changes with legal and/or compliance staff to ensure legal and/or regulatory compliance
Prepares training materials for end users to train on document management system
Supports on site audits by providing documents and information requested to the auditor
Review Document control submissions to determine change control impact
Stays abreast of document management technologies/techniques
Requires a Bachelor’s Degree in English or related field and 0-2 years medical quality, document management systems, or related experience
Knowledge of ISO 13485
Organizational, time management and interpersonal skills
May have to work overtime and may be assigned to other shifts based on company needs

Project Document Control Specialist Resume Examples & Samples

Completed higher degree education (preferably in technical or document control field)
Minimum 3-years previous experience in international project management/ construction in the role of document control specialist
Upper-Intermediate English skills (including technical)
Business minded and cost-conscious
Knowledge of document management and experience in workflow/ records management within major construction/ reconstruction/ building related Projects
Result and team work orientation

Document Control Specialist Resume Examples & Samples

Process documents through steps in accordance with procedures and guidelines
Support the development and maintenance of procedures
Ensure following of document control requirements (Example, which document numbering systems will be used; how many and which signature will be required for certain approvals, etc
Evaluate documents for completeness and accuracy
Maintain controlled document master list
Maintain training files and logs
May modify documents, as required or directed, in accordance with approved Quality and Engineering changes and policies or procedures
3-5 years’ experience in maintaining a document control system
Experience in assisting to create a new document control system would be beneficial
A.S. Degree in Engineering or a related technical field and 3+ years of document control experience. Manufacturing industry experience strongly desired
Experience operating in an ISO9001 manufacturing environment
Strong PC skills ( Microsoft Office, SAP/ ERP)
Problem solving skills and attention to details
Ability to be flexible and manage changing priorities

Document Control Specialist Resume Examples & Samples

Requires 2 to 5 years with BS/BA or 0 to 2 years with MS/MA/MBA or 8 to 10 years with no degree
Familiarity reading technical documents
Ability to interact with customers in a professional manner
TS/SCI with Poly required

Document Control Specialist Resume Examples & Samples

Receive and establish control and accountability for all incoming material and media, to include classified material/media upon arrival
Transmit all material and media in accordance with applicable DoD, DoN policy and the facility SOP
Verify storage capability of intended recipients of classified material transmitted outside secure facility
Prepare classified material for transmission to include preparation of external receipts, labels, envelopes, fax and registered mail receipts
May need to courier within 75 mile radius
Understand and comprehend JAFAN 6/4 personnel security requirements; process program access
Provide inventory report to the TSCO/ATSCO at least annually and participate in other directed inventories
Operate Secure Communications Equipment in accordance with facility SOP

Document Control Specialist Resume Examples & Samples

Coordinates and administers assigned configuration management activities relative to identification, control, and accounting for engineering documents, specifications, and vendor documents
Ensures that customer, internal and external, requirements are implemented
Perform assignments of limited scope and complexity following established policies and procedures under close supervision
Establishes procedures for and implements the introduction of changes to engineering documents
Reviews and analyzes engineering documents, specifications, and vendor documents coordinates changes with engineering and support
Production of engineering document and specifications for projects
2-4 years’ experience required, BioPharma or other industry experience referred
BA or BS required
MS Office skills (Word, Excel, PowerPoint, Access, Visio) required
Adobe Acrobat skills preferred
Ability to lift 15-20 pounds is required

Document Control Specialist Resume Examples & Samples

Enters and updates bills of materials and revisions using the SAP system
Makes corrections to Quality system and ISO documentation using Microsoft software
Maintains master sets of Quality System Documents; such as; but not limited to: Quality Manual, operating procedures; Work Instruction; Design History File and Device History Records
Maintains electronic documentation files located in Master Control
Manages processes used in MasterControl such as: Inspection sheets, Label approvals; ECO’s, Deviations, Training matrices, etc
Works with Engineering to prepare and/or Documentation
Reviews, maintains and/or corrects bills of material structure for new products to ensure accuracy
Assists in maintaining the MasterControl Database
Supports Documentation needs for Internal Customers
Conducts random production audits
Supporting continuous improvement activities or special projects
Helps to manages paper processes that are in use
Ensure we remain compliant
The ability to operate a computer, copy machine, and scanner and Ten-key by touch is desirable. The ability to work independently, excellent organizational skills and good interpersonal skills is needed
AA Degree required. Bachelor degree preferred
4 years of experience in both an office and manufacturing floor setting, including using personal computers, Word processing software and controlling documentation
Knowledge of Microsoft office applications, Electronic Documentation Systems (Master Control highly preferred), Adobe, network structures and ERP’s (SAP highly preferred)
Personal Trait Profile
Self-sufficient
Team orientation (knows when to lead and when to follow)
Lives the “continuous improvement” philosophy and can drive change successfully
Logical and creative thinker
Poised, strong personal impact
Ability to influence others – credible
Ability to articulate the DBS philosophy
Facilitation skills

Document Control Specialist Resume Examples & Samples

Maintain and continuously improve the Document Control system and processes to ensure compliance with current GXPs
Work with primary originators of documents to ensure that GXP-related SOPs and forms are reviewed, edited, formatted, and approved in a timely manner
Author Quality, GMP, and GXP related SOPs and forms as assigned, and work with functional departments to ensure accuracy, feasibility and completeness
Issue Document Change Requests (DCRs) and document status reports
Update and maintain document tracking spreadsheets, document databases (if any), including data entry for tracking documents
Provide guidance and training to employees on document control systems and procedures
Manage the document periodic review program
Obtain, monitor, and report on document control metrics, and oversee document control compliance for the Quality department
Serve as a training representative for Quality with other departments, and as a project resource for training projects, as required
Administer the GXP training program at FivePrime, including by maintaining master copies of all FivePrime training materials
Maintain complete and accurate training records for personnel involved in GXP activities and maintain an active list of all such personnel
Perform audits on training files to ensure that all GXP employees are meeting their training requirements
Assist managers and others in creating training curricula, materials, documentation, etc
Deliver training on document control and/or training procedures and practices as required
Evaluate the effectiveness of training programs, and implement recommended changes or enhancements when necessary
Obtain, monitor, and report on training metrics, and managing GXP training compliance
Provide additional support to the Quality organization as required including maintaining original Quality documents, loading PDFs into the Quality SharePoint, updating controlled lists, etc
Bachelor's Degree with 2+ years of relevant experience in pharmaceutical or biotech industry
Bachelor’s Degree in the life sciences preferred
2+ years of experience in a GMP Quality or Manufacturing position performing training administration or processing document changes

Document Control Specialist Resume Examples & Samples

Building the document control processes and tool sets for the Regional Office
Mentoring co-workers/team members on the document control processes
Establishing work priorities and objectives to meet tight deadlines
Receiving material into the system through direct contact with site construction managers
Participating in planning, and successful implementation of special requests made by Manager/Project Managers including special information needs such as the need to extract information from documents e.g. extracts list of project materials and provides to engineering
Taking part in the RFP/bidding process
Preparing spreadsheets of bid evaluations
Developing and maintains ongoing effective liaison with internal customers, including management regarding project requirements
Compiling statistical records of services provided including the amount of time required to process/produce documents
Assisting the Cost Controller in verifying vendor/subcontractor invoices and maintaining an up-to-date invoice register
Taking part in the preparation of client return data files
Preparing and issuing status reports for both internal and external clients
Entering and maintaining accurate information in both SNC-Lavalin T & D and client databases
Creating document control processes and ensuring that they are being followed
Arranging and attending meetings
Drafting, formatting and generating a variety of correspondence
Filing and/or scanning various project documents (paper and electronic files)
Providing ongoing support of the Engineering Library (including initial set up and organization)
Candidates must possess leadership qualities
A minimum of one (7) years of administrative or support experience
Proficiency in Microsoft Office, Visio, Power Point, and Adobe
Experience in the use of databases and electronic file management software
A willingness to learn new skills to add to document management expertise
Strong interpersonal and communication (written and oral) skills
Strong organizational and ability to deal with competing priorities and manage time appropriately
Experience in document control or records management is a MUST
Experience in a technical or engineering environment is a MUST

Quality Document Control Specialist Resume Examples & Samples

Follows standard practices and procedures when analyzing situations or data. Exercises good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Self-starter to complete tasks with little to no instruction on day-to-day tasks and workload
Experience leading teams and assuming a leadership role when judgment calls are required in the absence of Manager
Ability to build strong relationships with employees at all levels of the organization: internal and external
Liaison between Quality, Operations, PMO, etc., to ensure the appropriate changes are properly documented
Ability to enforce corporate standards and procedures in accordance with governing guidelines
Coordination with change order Originators to create, revise or obsolete documentation with the appropriate approvals
Track and coordinate change order completion, approval, and implementation
Strong interpersonal skills, time management, and organizational skills
Provide troubleshooting and audit assistance as needed
May perform some administrative duties such as filing and correspondence
May include other duties as defined by the Engineering Services department management
Must be computer literate with strong use of word processing, spreadsheet programs and databases
Use of some independent judgment and analysis required
Minimum of 5 years’ experience using Oracle eBusiness suite software
Minimum of 5 years’ experience using Oracle Agile PLM software
Medical device and biotechnology industry a plus
Minimum of 5 - 10 years of related work experience
Experience in a medical device company preferred
Proficient in Oracle Agile ERP and PLM systems
Oracle eBusiness Suite preferred

Document Control Specialist Resume Examples & Samples

Coordinate with and assist company internal departments to effect a timely and accurate preparation of order related documents. Types of documents involved include Certificates of Conformity (COC), Material Test Report (MTR), Weld Maps and Reports, and others
Assemble and transmit documents to customers in accordance with sales order contract terms, such as periodic project update meetings or final document packages at time of shipment
Receive and distribute customer document change requirements to affected departments, and follow up to ensure timely revisions and re-transmittals
Maintain an up-to-date status of all project-specific documents
Maintain accurate and up-to-date archives for all project-specific documentation
In coordination with Project Engineer, ensure all document requirements are completed in accordance with contract schedules
Drive continuous improvement activities related to the document control processes, procedures and software applications
Communicate document control standards to all company departments
Produce Document Control status reports, metrics, charts and graphs as requested for management review
Assist and support the Projects Group with Third Party Inspection visits when documents are requested
Minimum Education: High school diploma; some post-high school education a plus
Minimum Experience: Three years of document control experience in a manufacturing environment
Very strong computer skills, including proficiency with Microsoft Outlook, Word and Excel. Experience with Sharepoint and/or MS Access would be a plus
Superior attention to detail and commitment to meeting schedule requirements
Strong organizational skills and the ability to multi-task
Ability to communicate effectively, both verbally and in writing, with all company departments, subcontractors and customer personnel
Some experience in the energy industry is a plus

Document Control Specialist Resume Examples & Samples

Accurately enter all documents and media into the SIMs database
Ensure all material is marked in accordance with Executive Order 13526
Ensure full accountability requirements by logging, assigning ownership, tracking and certifying destruction of all
Bachelors degree with 5-7 years experience
2-4 years experience in Industrial Security, classified document/media control
Experience in an industrial security setting
Confident and professional demeanor and appearance
Flexibility to do whatever task is required and willingness to learn new functions
Self starter able to work with a team
Solid working knowledge of JPAS
Experience securing closed areas such as locking and setting alarms
Experience managing individual visitors and large groups of meeting attendees
Solid working knowledge of NISPOM requirements
Defense Security Service Academy course work including Essentials of Industrial Security Management, Protecting Secret a d Confidential Documents, Derivative Marking Requirements, Industrial Security Facility Database,
02-04 years w/Masters Degree

Document Control Specialist Resume Examples & Samples

Receive and register controlled records for the Watson Health organization
Strictly adhere to good document practices for attributable, legible, contemporaneous, original and accurate record management
Create and maintain a filing system that supports efficient management of all controlled records by ensuring proper document classification, sorting, filing and proper archiving
Send and receive documents from worldwide teams, prepare paperwork for contract agreements, and ensure all records-management activities adhere to policies and legal regulations
Maintain specifically assigned project databases of all filed controlled records
Full traceability and accountability of all controlled records
Performs quality checks in accordance to IBM Watson Health Standard Operating Procedures
Collect and maintain files of the latest revision level documentation necessary in accordance to IBM's Watson Health Standard Operating Procedures
Timely distribution of latest revision level documentation to all appropriate users
Perform file backups to ensure proper storage and archiving of electronic registers
Prepare project reports, as needed
Perform clerical typing duties, as necessary
Periodic reconciliation of document record inventory
Completion of at least 4 years of college education, preferable with relevant years of experience
Previous Document Control experience in the Health Care and Life Sciences industry preferred
Familiarity with GxP, Quality Management systems, HIPAA, Training Records, SOPs, etc. preferred
Self-directed and highly-motivated
Detail-orientated, dependable, and trustworthy
Outstanding organization and follow-up skills required
Excellent knowledge of the Microsoft Office suite
Good working knowledge of Adobe Acrobat
Familiar with e-Document management systems
Excellent command of written & spoken English and ability to prepare reports and statistics

Document Control Specialist Resume Examples & Samples

Minimum of at least 8-10 years experience on WSDOT and/or LAG projects involving Federal funding is required
Bachelors degree or related experience with a minimum of two years' experience in construction or design activities desired
Must be computer literate with solid working knowledge of Microsoft Word and Excel

Document Control Specialist Resume Examples & Samples

Maintains files of engineering drawings, specifications and documentation
Prepares process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness
Ensures documents meet standards for production
Comply with information security policies and procedures implemented by Itron
Protect Itron and customer information assets to safeguard confidentiality, integrity and availability
Excellent English + Hungarian languages skills, written and spoken are mandatory
You already have worked with Business Managements Systems ISO9001 & ISO27001
Ideally you have gained a related experience of 2-4 years in change control
Experienced use of corporate PDM/PLM/MRP/ERP tools, Oracle will be a plus
You are open to new ideas and adapt quickly necessary changes, as well as you have attention to details and accuracy
You will work independently, able to work under pressure and to meet timelines and requirements
As part of a global team, you consider yourself as team player and you are able to share knowledge and to support others to meet goals

Document Control Specialist Resume Examples & Samples

Maintains technical documentation for each project to include tracking, logging and maintaining all required engineering, architectural and construction documents, vendor submittals, shop drawings, design review records, special studies, etc
Provide support for the development and administration of a Virtual Team Website, ensures that system is populated with proper data in the proper file structure, provides assistance to system users in locating information and maintains security administration of the system
Performs regular document audits
Ensures that proper project procedures are adhered to
Ensures that all required signatures are included on project documentation
Provides input for the development of project procedures and analyzes project-related data
Produces project status reports, technical reports, worksheets, etc
Maintains the project’s library of technical documents
Maintains archived engineering, architectural, and construction documents, including design drawings, vendor submittals, shop drawings, design review records, special studies, and other documents as required
Transports documents to and from reproduction facilities as needed
Reviews drafts and finished documents for grammar usage
May design processes to enhance work flow
Multi-tasking / juggling between different managers and tasks as required
Following-up on multiple requirements needed for the project
Coordinating schedules and organizing team to accomplish tasks
Bachelor degree is desired
Requires at least 4 years of experience as a document control specialist is required
Engineering, architectural, and construction documents (i.e., maps, drawings, technical specifications, etc.) experience is preferred
Requires excellent organizational, interpersonal, and communications skills
Must exhibit professional behaviors and appearance and be aware of the importance of teamwork within the assigned department
Ability to read, write, reason, analyze, evaluate, problem solve, perform mathematical calculations and allocate resources as appropriate
Software: Microsoft Office: Expert level experience with Outlook, Word, Excel, PowerPoint, etc., SharePoint, and ProjectWise v8i

Document Control Specialist Resume Examples & Samples

Function as the Document Management System administrator (QM1) for the Rochester site. This includes managing user permissions and insuring documents are reviewed by the owners as required
Establish and manage a document archival system for both paper and electronic records
Support regulatory and customer audits as required supporting document management
Ensure a local Document Management SOP is written, is consistent with Lonza GROUP procedures, and is kept up to date
Function as a “back room” lead during regulatory and customer audits

Document Control Specialist Resume Examples & Samples

The Document Control Specialist receives reviews and classifies incoming quality systems records and supporting materials
Reviews incoming validations for good documentation practices and partners with process owners to ensure documentation errors are corrected prior to scanning
Logs incoming documentation such as design history records, validations, CAPAs, lab notebooks, in a centralized archiving system
Manages all phases of the Periodic Review of Procedures process
Creates files, labels and barcodes incoming records
Scans Device history Records and uploads electronic files into centralized archiving system
Locates, retrieves, and delivers records requested by internal customers
Prepares files for storage based on the company’s record retention policy
Prepares records for destruction as defined in the company’s record retention policy
Responsible for inventory transactions such as checking in/out original records, resolving issues and tracking past due items
Initiates Non-Conformances due to documentation errors and works with area owner to complete corrections
Performs technical and clerical assignments involving data entry, proofing and other administrative duties
Demonstrates a sense of urgency and timeliness for assuring optimal record management
Carries out duties in compliance with established business policies
Assists in regulatory inspection activities
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

Document Control Specialist Resume Examples & Samples

Analyze and process Change Orders and Deviations utilizing the JDE system
Monitor Change Order and Deviation approval/implementation and be able to assist in resolving issues
Interface with Engineering, Manufacturing, Field Service and Quality departments, to verify ECOs and other related change documents
Perform data entry functions as required by the JDE processes
Assist in issuing part numbers and creating Product Structures to support NPI and sustaining activities
Ability to coordinate activities based on given priorities
Ensure standard practices and procedures are followed when analyzing data. Exercises judgment within defined practices and policies in selecting methods and techniques for obtaining solutions
May include other duties as defined by the department Manager

Document Control Specialist Resume Examples & Samples

Responsible for generating and processing change requests
Ensure procedures are ISO compliant
Proof documents updated and generated by other team members
Maintain records of all change orders
Ensure controlled documents are handled properly, red line is done correctly and other ISO procedures are followed
May maintain print room server
Update and load Item Master data

Document Control Specialist, Suzhou, SPS, SPS Resume Examples & Samples

Analyze proposed changes of product design to determine effect on overall system using knowledge of engineering, manufacturing and procurement activities
Responsible for full and accurate configuration and documentation control of all purchased and manufactured components and assemblies
Responsible for the coordination with manufacturing of all prototype and qualification builds
Participate in improving CM processes and products. Identify issues and areas for improvement in existing processes, either independently or as a member of cross functional teams
Minimum of 5-8 years experience in SAP MMPP/PLM
Travel required (Domestic & International) as needed. <15 % of the Time
Creative problem solving and negotiation skills

Document Control Specialist Resume Examples & Samples

Prepare, operate and update Document Control Procedures in line with the Company’s Document Management System
Prepares and implements document controls processes to ensure procedures, correspondence, instructions and other project documentation are properly approved, issued, distributed and maintained
Maintain minimum processing standards and meet deadlines by working in a high-pressure environment at a fast pace while maintaining quality and error free work
Liaise with customers on documentation transmittals
Produce and maintain Document Progress Reports to Project Managers and other interested parties
Ensure all documentation provided is as per Client quality formatting requirements. Formatting may include correcting templates, fonts and style, pagination and numbering and other activities that may be required to achieve a client’s documentation requirements
Work in strict co-operation with Project Managers to ensure project progress status integration
Responsible for oversight, structure and maintenance of all document management systems & tools
Ad hoc duties as required to support the project teams
Practical / hands-on experience in document management roles in EPC projects of at least 5 years
Basic understanding of Engineering / Procurement / Construction / Commissioning documents
Self-directed and highly-motivated with ability to prioritize tasks and communicate at all levels
Excellent MS Suite software knowledge
Good working knowledge of Adobe Acrobat & BOX
Familiar with e-Document management systems (Sharepoint, etc.)
Identify and report any quality or compliance concerns and take immediate corrective action as required. 1. Minimum one year experience in project management
Excellent verbal, written, and communication skills
Proficient in soft skills that are necessary to be an effective project manager
Negotiation skills and experience
Ability to monitor and manage critical path elements of consolidated projects
Ability to make presentations (internal and external)
Experience managing revenue generating projects
PMI certification
Problem resolution skills and creativity in solution development
Vendor implementation experience

Document Control Specialist Senior Resume Examples & Samples

Understanding of FAR regulations on pricing information and contractual communications
Detail-oriented mindset and reliability to insure high quality and control for retrieval as end product
Flexibility and adaptability to work alone or on teams
Strong PC skills with the ability to quickly learn new software programs. Proficient to advanced in Microsoft Outlook, Word, Access, Excel and Adobe Pro. Recommended but not mandatory to have SAP or Oracle based ERP system experience
Experience in Oracle Contract Manager and SharePoint Databases
Minimum four (4) years working in a business/administrative environment
High school diploma or the equivalent
Bachelor’s degree in an associated discipline preferred

Document Control Specialist Resume Examples & Samples

Monitor compliance with the Company’s document control procedures and requirements, control deviations and follow up their correction
Assist in training staff in the Company’s document control processes and associated tools
Check incoming documents for readiness prior processing
Update registers and the Electronic Content Management System (ECMS) for the documents being processed
Distribute documents by hard copy and electronic means, including arranging copies
Filing and Archiving of documents
Reporting on document control processes
Administer the document lifecycle (author, approve, publish, revise, retire, archive) engineering, Construction documents and other business policies and procedures
Support in the performance of quality reviews and audits
Scan documents, update procedures,
Assist in other related tasks as requested by the Document Control Manager
AA or BA degree in a related field a plus
Strong understanding and capabilities in utilizing naming and numbering conventions for receiving, recording, filing, transferring, transmitting, retrieving and archiving documents
Must possess the ability to understand the underlying document control principles involved and a strong initiative to apply them
Must possess character traits of being accurate, meticulous, proactive, efficient, self-organizing, a team player
Must be proficient in common software, particularly MS Office; training for ECMS software is provided
Experience in construction works and familiarity
LI-ST

Document Control Specialist Resume Examples & Samples

Effective (local) Business Process Ownership/Expert role for Document Control processes and tools in scope
Establish DC support to authors and (local) process owners in defining and producing lean Quality System documents and records; ensure proper quality of the content of documentation and records
Manage proper document review processes
Ensures availability/publishing of controlled documents
Monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business
Manage DHF/DMR/DHR
Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties
Strong attention to details
Ability to organize and prioritize workflow and to meet established timeframes
Ability to maintain updated knowledge of procedures, products and activities of assigned area
Manage and Lead teams doing quality inspections
Evaluate, update, and deploy new processes and process improvements
Two year technical degree
CMII certification (or other equivalent configuration management certification) preferred
Knowledge of Lean Manufacturing concepts a plus
Knowledge of Six Sigma concepts preferred
Ability to perform multiple tasks concurrently with accuracy
Demonstrated understanding of FDA Good Documentation Practices (GDP)
Clear and effective communication skills

Document Control Specialist Resume Examples & Samples

Document Control subject matter expert and represents the worldwide documentation control department as required
Supports Agile users to assure timely, accurate and efficient document generation and revision
Maintains and administers Document and Change Control procedures in compliance with cGMP and ISO 13485 document control regulations and guidelines
Executing to key performance indicator metrics for documentation control including preparation and distribution of reports as needed
Provides support documentation to meet customer and FDA requirements as well as documentation preparation required for internal, customer, and 3rd party audits
Ensures cGMP documents are maintained in a secure and organized manner and ensures documentation is retrievable and accurate
Manages retention of applicable corporate, regional, site monthly meeting materials, minutes or files as required
Monitors and tracks the review, approval, and distribution of documents to ensure timely completion to meet established time lines
Resolves complex Document Control issues
Responsible for managing on site storage of documentation and serve as interface for off-site provider as required
Reviews change control packages for correctness and completeness
Manages secure database directory and documentation processing functions and determines appropriate access for users
Provides Document Control guidance and support, such as training and troubleshooting, to the user community as required
Provides overall guidance/leadership for regulatory documentation services and practices
Provides documentation assistance on non-design / R&D Projects
Provide 2D/3D CAD support to departments as required
Provide support to acquisition and integration activities

Document Control Specialist Resume Examples & Samples

A Bachelor’s degree in science or engineering or a discipline appropriate for management of quality system documents and records, with 0-2 years of broad experience in a regulated business (e.g. Cosmetic, Drug or Medical Device)
Demonstrated evidence of a background of technical knowledge and experience in the area of document and record Management, including at least a general understanding and awareness of FDA regulatory requirements and ISO Standards for document and record control
Advanced computer software skills, including proficiency in most or all of the following: wed based computer systems (e.g. CompliantPro, EtQ), Adobe Acrobat, Microsoft Outlook, Visio, Word, Excel and PowerPoint. Familiarity with SAP is preferred
Proficiency in English and Spanish, with the ability to perform document translations between English and Spanish, is preferred. Document translation experience is helpful and certification is preferred
Experience should include close working relationships with Business, Marketing, Manufacturing and Research functions
Experience should include knowledge of FDA Quality System requirements for cosmetics, drugs and/or medical devices
Previous technical experience within QA/RA and or R&D would be a plus

Document Control Specialist Resume Examples & Samples

Adhere to and enforce established document control procedures in order to ensure compliance to quality system requirements
Coordinate document administrative reviews, release and distribution. Maintain accurate data in the Document Control EtQ database and other document control reference files. Maintain accurate control copy and master files, both hardcopy and electronic
Ensure adherence to procedures for record control and retention and other required processes for managing quality records
Participate in investigations that require evaluation and assessment of the quality impact to Quality System processes as required
Coordinate retrieval and staging of current documents for internal and external audits
Manage the site Change Control process and trending
Facilitate daily communication related to Quality System Records
Assist with the planning and execution of the Management Review Process
Tracking and Trending of Quality System elements as required
Associate Degree or higher in a relevant discipline, plus
1-2 years of experience in document management and control
Process
Relevent understanging of Quality System requirements in a
Excelent computer skills with proficiency in Microsoft Office and other web based computer systems

Document Control Specialist Resume Examples & Samples

ISO 13485: 2003/2016 Medical Device Quality Management System Requirements pertaining to document and record control
FDA 21 CFR part 820 Quality System Regulations pertaining to document and record control
High school diploma or higher
5+ years experience or equivalent combination of education and experience working in an FDA and ISO 13485 regulated environment
Strong communication, technical, and computer skills
Coordination, tact and team work
Familiarity with an FDA and ISO 13485 compliant document control system a very big plus

Document Control Specialist Resume Examples & Samples

Demonstrated knowledge of document management system
Demonstrated communication and coordination skills with all levels of staff, entities, disciplines and departments
Conscientious, organized and meticulous – records must be accurately maintained
Advanced computer skills in MS Office preferred
Fluent in English, oral and written required
Fluent in English, both oral and written required
Regularly communicate and collaborate with Supervisor progress statuses, concerns and questions
Ability to adjust work schedule to accommodate unexpected changes
Maintain a comprehensive engineering drawing and document control electronic filing system, working for the refinery and the fertilizer plant
Collect and ensure that the filing system contains the latest version for all documents and obsolete documents are archived
Posts changes to computerized or manual control records, releases approved documents and notify affected departments
Perform clerical duties, scanning, printing, etc., to distribute updated versions of all documents
Regularly communicate with supervisor work progress, concerns and questions
Effectively maintain up-to-date version of all documentation in the filing system
Project documents are prepared and managed to deliver projects and services under contract in the most efficient and effective way
Maintains a current knowledge of relevant issues, trends and practices in relation to AutoCAD systems and procedures
Adherence to all company policies and procedures

Qaqc Document Control Specialist Resume Examples & Samples

Organize archival records and develop a standardized classification systems to facilitate access to archival materials
Arrange and coordinate the storage and retrieval of important files and regulatory documents related to non-clinical and clinical data (i.e., study documents, report, lab notebooks, specimens, case report forms, etc.)
Administer controlled documents and be responsible for administration of controlled document system(s)
Control all documentation which supports regulatory requirements and oversee completion of the following within document control: word processing, revision processing, proof reading, photocopying, circulation and tracking of documents, final distribution of documents, and maintenance and security of the document FDA Sponsor Master-files
Establish and comply with procedures for maintaining documents and change control of documents
Maintain accurate and secure filing systems for documentation to include current active/effective documents, in-active documents, and obsolete documents, including historical information
Review in-progress and final work products to verify that internal Standard Operating Procedures (SOPs) are being/have been followed
Participate in process improvement programs
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer
Performs light duties and other related duties as required and assigned
Proficient with Microsoft Office (Word, Access, Excel, PowerPoint) and Adobe software applications, PDF editing software, and able to research and review content effectively and interpret information into clear and concise scientific writing style
Possess 2 or more years of experience in document control
Must be able to work independently following a brief period of specific technical training
Have the ability to obtain secret clearance

Document Control Specialist Resume Examples & Samples

Edit reports, publications, and correspondence to ensure clarity of content, consistency of format and accuracy of grammar
Utilize personal computers with integrated software packages
Participate in the development and maintenance of SOPs. Assist with the validation/verification, discrepancies/deficiencies resolution, and accuracy/adequacy assessment of technical manual; requirements for printing
Apply working knowledge of technical literature and various style guides including in-depth documentation and publication standards
Assist in the production and distribution of documents
Maintain a filing system of documents and work order files for documents received for processing

Document Control Specialist Resume Examples & Samples

Compiles and maintains control of records and related files to release blueprints, drawings, and engineering documents to Construction Department colleagues, outside engineering firms and vendors
Manages Document Control SystemManages, stores, transmits and monitors flow of documents involving vendors, Architect Engineers and Covanta project teams
Posts, scans, copies and files transmittals, drawings and specifications
Maintains and manages document management systems (DvTDM), including troubleshooting, upgrades, testing, training team members, and coordination with IT
Expedites turnaround time of drawing and specification reviews. Runs reports showing status of documents by project

Document Control Specialist Resume Examples & Samples

Establishing a procedural framework for identifying, collecting, distributing and filing the controlled documents. This involves proof reading, writing and maintaining document control procedures
Timely distribution of latest revision level documentation to all appropriate users on production lines and ensure that obsolete documentation is removed from distribution
Ensure the information and management control system is implemented in compliance with the ISO 9000 standard; and is updated to reflect revisions to those standards
Ensure the Project Team members are provided with adequate training and support to enable them to successfully use the procedure and systems in use. Proactively conduct "spot audits" and "over-the-shoulder-reviews" of Operation Teams to facilitate their understanding of and enhance their compliance to Document Controls procedures
Provide Quality Assurance / Quality Control (QA/QC) audits of the hardcopy Document Control files and the Prolog Electronic Document Control files
Must be able to occasionally wrap, lift and move boxes/packages of up to 40-pounds

Document Control Specialist Resume Examples & Samples

Document Control Responsibilities for Volcano AtheroMed Quality System-process ECO’s and update documents, and controlled document locations. Document control responsibilities including support of preparation of regulatory filing(s) and /or clinical study material as required
Support in maintaining Training and other QSR related documentation
Assist in implementing PLM based Document Control and responsible for maintaining PLM system once implements
Provide ongoing support to the Senior Director, Atherectomy Operations and Senior Management Staff at Menlo Park, as well as provide miscellaneous administrative support to other personnel on an as needed basis
Support Purchasing, including drafting and sending POs as required
Support, assist, and A/P and related activities as required
Maintain a safe, clean, and QSR compliant facility - this may include coordinating janitorial and other building services in addition to resolving safety hazards
May act as safety team leader
Communicate regularly with the employee population regarding relevant facilities issues
Prepare necessary documentation for shipping
.Perform other duties as assigned
Minimum 3 years related experience in office and facilities management
Familiar with Microsoft Office, including Word, Excel and PPT
Working knowledge of electronic document
Familiarity with PLM Systems desired
Working knowledge of desktop computer office software
Familiarity with Windchill PLM a plus
Document Control experience for a medical device company or regulated environment is highly desired

Document Control Specialist Resume Examples & Samples

Research quality system documentation to identify discrepancies and follow-up with appropriate departments to achieve resolution
Verify through auditing that quality system procedures and documents are accurate
Create or modify quality system documents as appropriate in coordination with department coordinators
Audit and reconciliation of batch sheet, control batch sheet changes
Develop tools to track errors and identify corrective action
Develop trend reports for corrective actions and follow-up to monitor effective resolutions
Verify through auditing production records that batch record reports are accurate and balanced
Assist with root cause analysis when discrepancies are found through all quality system audits

Document Control Specialist Resume Examples & Samples

Implement document control processes and ensure global consistency or alignment
Ensure document control procedures comply with local or country specific regulations as well as internal policies and procedures
Be responsible for maintaining the change control process in Arena, including the review of change control documents and deliverables
Coordinate with other functional areas to ensure accurate, complete and efficient change control processing
Review and assist in resolution of documentation issues (e.g. change control, document archiving, procedures, etc.) and translations
Review all electronic documents submitted to change control for correct formatting, spelling and clarity of text before obtaining approval
Track, follow-up and implement change control records
Interface at all levels with all departments to service their requirements in an efficient professional manner
Create and maintain all hard and soft copy master files for active and archival documentation
Assist with all department projects as required
Ability to communicate and interact with customers of various education levels and cultural diversity
Demonstrated ability to manage time effectively, prioritize multiple requests, and meet deadlines
Ability to efficiently create, edit, and format Word, PowerPoint, and Excel documents
Proficient in English language
1 -4 yrs. experience in an electronic documentation environment
Familiar with ISO Standards
Excellent advanced Computer skills in Microsoft Word and good skills in Excel, Power Point required
Working knowledge of other specialized programs such as Visio, Illustrator, Photoshop or Acrobat desired, not required
Knowledge of Arena or Agile PLM systems a plus

Document Control Specialist Resume Examples & Samples

ERP/ Data Entry Experience, input into JD Edwards business system
Verifying/ updating part numbers
Revisions on parts
6 month length of assignment
Must be flexible to work from 7am-5pm, 8 hour shift fixed start time, can be around 7AM
Configure Management experience needed, Configuration management of engineering records

Document Control Specialist Resume Examples & Samples

The Doc Control Specialist will download test equipment
The Doc Control Specialist will create computer generated labels for job sites
The Doc Control Specialist supports sales team in making bid binders
The Doc Control Specialist will back-up Auto-Cad team as required
The Doc Control Specialist will perform other duties as assigned
Must possess at least a High School diploma or GED equivalency
Must possess a minimum of one (1) year of administrative experience in telecommunications or related technical field
Must be an advanced user of Microsoft Office Suite (Word, Excel, and PowerPoint)
Experience with Bluebeam software preferred
Must have the mental capacity to learn, understand and apply job-related concepts, technologies, instructions, procedures, computer and software operations, input data and create/annotate drawings with a very high degree of accuracy on a consistent basis with high throughput and minimum supervision

Qaqc Document Control Specialist Resume Examples & Samples

Posses a basic understanding of medical products(drugs, biologics, and devices) and the Code of Federal Regulations (CFR)
Knowledge and experience writing, reviewing, and/or editing Common Technical Document (CTD) submissions
All contractors performing this work require access to IT/ADP Level II
Ability to obtain secret clearance

Document Control Specialist Resume Examples & Samples

Collaborate on the development and later management of a Configuration Index (CI) of all program documents that will fall under Configuration Management (CM) control
Maintain the flow of electronically-controlled documents; storing, arranging, indexing and classifying records
Follow and maintain version control of project documentation requirements
Understands the documentation and procedural expectations, and have a clear understanding of Information Management Policies and Procedures
Follows company standards, policies and procedures for document control to ensure compliance and audit expectations
Ensure compliance with document management standards and procedures including adherence to program document numbering practices and electronic repository structure
Process all document changes including administrative clerical checking for accuracy and completeness
Perform occasional Gap Analysis of the CM process to identify areas for training
Propose recommendations for improving content management system capabilities
Develop, document, and maintain standards and best practices for system usage procedures
Consult with end users regarding problems in accessing electronic content
Monitor management system activity to maintain compliance with records and document management requirements
Retrieve electronic assets from repository for distribution to users, collecting and returning to repository, if necessary
Prepare and record changes to official documents and confirm changes with management staff
Identify and classify documents or other electronic content according to characteristics such as security level, function, and metadata
Train new and current project members on CM tasks as needed, serving as a resource to others
Solves moderately complex problems and/or conducts complex analyses
Work with minimal guidance
Experience using Microsoft Office 2010 or later, and SharePoint 2010 or other document management tools
Strong planning, analytical, organizational, verbal and written communication skills
Strong background in documentation version control
Ability to work with a high degree of accuracy and recall
Ability to handle confidential or sensitive information with discretion
Healthcare and/or insurance experience preferred
At least two years of records management experience preferred
Experience with configuration and change management processes in a CMMI-aligned organization highly preferred
Certification in Document Management or a related field preferred (e.g., AIIM)

Document Control Specialist Resume Examples & Samples

Input document data into PLM and manage change orders
Format production batch records submitted by scientists
Maintain batch record files from review to archival
Manage, launch, and track DNCR and CAPAs
Provide data analysis from PLM and Quality system
Generate labels from design to print
Work closely with developers and manufacturing staff to understand the products and required information in PLM system
Bachelor degree or equivalent in Production Management, Business Administration, Records Management
2-3 years of relevant industrial experience in Life Sciences or equivalent industry, demonstrating capability in all aspects of the job requirements
Ideally has worked with reagent and instrumentation products
Strong teamwork, leadership, organization and communication skills

Document Control Specialist Resume Examples & Samples

Schedule meetings and appointments; prepare agendas and coordinate travel plans for internal and off-site meetings as requested
Develop moderately complex spreadsheets typically requiring the creation of basic formulas
Prepare correspondence, presentations and reports with minimal guidance using word processing and graphics software
Take notes at department or committee meetings; transcribe notes and distribute to meeting participants
Participate on projects or teams as assigned
Maintain department records; prepare and track expense reports, check requests and purchase orders
Monitor office supplies and order as needed; ensure office equipment is maintained in good working order
Collect and compile data for entry into database system; maintain information in system
Create and maintain project filing systems
May provide general guidance to office staff as needed
Work closely with Engineering teams, vendors and consultants to efficiently recieve, distribute and track project documents including proposals and AutoCad drawings
Thorough knowledge of current office procedures
Strong clerical and administrative skills
Proven communication and interpersonal skills
Demonstrated ability to organize and prioritize assigned tasks
AutoCad a plus
3+ years’ experience in an office environment, preferably in a similar role
Proficient with word processing software
Or any equivalent combination of education and experience that demonstrates the ability to perform the key responsibilities of this position

Document Control Specialist Resume Examples & Samples

Prepares documents for scanning by removing paper clips and arranging pages
Scans records using high-speed flatbed scanner
Performs quality control of documents entered into PDM system, which includes page count reconciliation, file renaming and ensuring optimum resolution of scans
Routes and releases documents in Product Data Management system
Performs cleaning of vital components of scanner and computer work station on a regular basis
Travel between local Pittsburgh sites will be required (35%)
High School diploma or equivalent is required; one year of vocational training or college is preferred
6 months - 1 year of experience in document/records management role
Knowledge of scanning/copying/indexing functionality
Effective usage of English grammar, syntax, punctuation and proofreading
Proven skills in organizing work, attending to detail and taking direction
Proven skills in managing time effectively and prioritizing activities

Document Control Specialist Resume Examples & Samples

Works on Item Master creation, enrichment, and maintenance in PLM => ERP
Manages project document release work
Works on less complex BOM maintenance work
Produces ERP Engineering change processing and implementation
Insures the master drawings are accurate and current
Experience 0-1 year

Document Control Specialist Resume Examples & Samples

Collect and maintain latest revision level documentation necessary to define product configuration and control of manufacturing /Wafer Fab processes
Perform all Document Control related activities including but not limited to reviewing incoming data to identify gaps, formatting and updating various types of documents, getting them approved in a timely fashion and releasing them in Agile
Interact with Design/Engineering Department to assist with creating Part Numbers and BOMs including releasing design review/gate-exit document package
Manage ECOs/MCOs/Deviation requests and its implementation
Prepare monthly reports and charts, as necessary
Perform clerical duties such as verifying accuracy of documents submitted, obtaining signatures, etc. - other duties may be assigned, as required
Ability to manage time well, multitask and troubleshoots with strong attention to detail
Ability to manage several tasks at once with the knowledge and experience to effectively prioritize
Ability to handle high-pressure situations in a professional and effective manner
Must be self-motivated and enjoy working in a rapidly changing and communicative environment
Excellent interpersonal and communication skills and the ability to work with all levels throughout the organization
Must have a commitment to excellence, the ability to anticipate change and create innovative solutions
Dependable, disciplined and well-organized
AGILE EXPERIENCE IS A MUST AND REQUIRED
Associate Degree with minimum 3 years of equivalent document control experience executing the above listed responsibilities
Experience in accessing and managing files in a PDM system
Computer literacy in a Windows environment (Microsoft Office Suite -Word, Excel, PowerPoint, and Outlook)
Must have basic understanding of mechanical and engineering drawings

Document Control Specialist Resume Examples & Samples

Good organizational and leadership skills
Advanced knowledge of office machinery such as copier and scanner
Advanced knowledge of in-house scanning system products, policies and procedures
Knowledge of alphabetical and numerical filing systems
Good leadership skills with the ability to work under limited supervision
Five (5) years’ experience in a similar role

Document Control Specialist Resume Examples & Samples

Effective local expert for Document Control processes and tools in scope
Relevant academic degree, preferred technical degree or Practical Engineering
Procedural or Technical writing experience
1 to 2 years related experience in change control and or document control field
Familiarity with Document Management tools
Experienced in good documentation practices
Understanding document control requirements in the medical device industry or other regulated industry
Background in change control
Knowledge of ISO/FDA regulations (Quality System Regulations) and regulatory requirements - an advantage

Document Control Specialist Resume Examples & Samples

AS degree from accredited college with 5 years of overall experience with 2 years specifically in proposal/documentation preparation.. ..OR.. .. HS degree and 7 years of overall experience with 2 years specifically in proposal/documentation preparation
Previous experience with Utility and/or Industrial electrical Power related projects and/or products highly preferred
Knowledge of SAP preferred
Previous experience supporting Project Management or Engineering team
Previous experience with documentation and /or drawing software
Local candidate to Lake Mary FL region

Document Control Specialist Resume Examples & Samples

Effective expert role for Document Control processes and tools in scope
Establish Document Change support to authors and (local) process owners in defining and producing lean Quality System documents and records; ensure proper quality of the content of documentation and records
Establish and manage proper document review processes
Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business
Train and support end users in the use of the document management system
Experienced in good documentation practices (changing and managing the revision process and managing documents in and out)
Understanding document control requirements in the medical device industry
Experience with Microsoft SharePoint platform (similar tools ok)

Document Control Specialist Resume Examples & Samples

As the Document Control Specialist, you will coordinate administration, accounting and facilities support for all functional areas of company Utilize the document management system and ensure fast retrieval of documents & records
Ensures proper document classification, sorting, filing and proper archiving
Reviews completeness of documentation and prepares document transmittals
Ensures that all controlled Quality documents are maintained to the latest issue, and that these documents are made available at all locations where operations essential to the effective functioning of the Quality Management System are performed
Ensures that all obsolete documents shall be withdrawn if retained for record purposes
Supports (local) authors of controlled documents to be lean, accessible, easy to maintain and according to the agreed look and feel
Ensures Document Control is established and ensures training
3+ years of Document Control experience
Medical/Healthcare background is a plus
Engineering background is a plus

Document Control Specialist Resume Examples & Samples

Coordinate the revision process of Standard Operating Procedures (SOPs), forms and other controlled documents. Assist in organizing QA records and archiving
Maintain historical files for SOPs and forms
Assure that site document management strategies and regulatory requirements for electronic documents are upheld
Enter, update and edit controlled documents and coordinate requirements for new documents with internal customers
Maintain the Master Schedule
Serve as the site system administrator for Document Management and QMS serving all Charles River operations which includes responsibilities for establishing user accounts, assigning roles and access and privileges
Assist in QA auditors with QA record archiving and administrative support
Manage the daily flow and final release of controlled documents through the document management system
Serve as the local site system administrator for the Document Management System including responsibility for establishing user accounts and assigning roles and access and privileges
Education: High school diploma or General Education Degree (G.E.D.) Associate’s degree (A.A./A.S.) preferred
Experience: One to two years related experience in data entry and document management. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
Certification/Licensure: None
Other: Basic computer skills required. Computer literacy in word processing and database record keeping experience required. Basic knowledge of medical terminology preferred. Attention to detail and the ability to organize and prioritize work and meet deadlines required

Document Control Specialist Resume Examples & Samples

2+ years of Systems Application Data Entry experience
Previous experience in the Medical Device and/or Pharmaceutical company
Experience in Medical Device or Regulatory environment
Working knowledge of Windchill, TrackWise, and/or Documentum

Document Control Specialist Resume Examples & Samples

Responsible for project managing the process of change control
Support the coordination, preparation and implementation of controlled documents via document change orders and engineering change requests
Review and edit product documentation for consistency in content. Interact with appropriate departments to resolve discrepancies
Review documentation, determine required approvers and route corresponding DCO//ECR in Agile. On completion of change, ensure manufacturing documentation is available at the point of use. Notification to appropriate departments
Facilitate and coordinate changes, enter and maintain documentation for existing products
Provide prompt, complete distribution of changes and rejected change requests
Enter relevant data on system pertaining to Batch Record Sheets, Incoming QC Specs, work instructions and SOPs
Compile master data for entry into Agile document management system
Transfer documents to new approved templates
Perform all job duties in a safe manner and obeys all safety policies and procedures
Perform all job duties consistent with the Code of Ethics and the 4-I values
Requires a minimum of 2 – 4 years relevant experience in a data management, manufacturing, or quality role in a change control environment
Knowledge of computer applications and current software is desirable (Microsoft Excel, Outlook, Word, Access, Project and PLM/ERP system
Experience working in an ISO 9001 or ISO 13485 environment
Works independently on new and on-going assignments
Continuous improvement minded

Document Control Specialist Resume Examples & Samples

Collect and maintain files of the latest revision level documentation necessary to define product configuration and 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
Manage records and logs as required
High School and four (4) years additional education and/or experience
Three (3) to five (5) years of related experience
Thoroughness and attention to detail
Strong technical capacity

Document Control Specialist Resume Examples & Samples

Issuance and control of all Specs, Methods, Templates, Worksheets, BMRs and
Criminal background check
Drug testing
Recent and relevant employer references
Education verification
500 and 1000 companies to provide workforce solutions. We offer many direct hire

Document Control Specialist Resume Examples & Samples

Analyze and process Change Orders (COs), Change Requests (CR), and Deviations utilizing change control and Enterprise Resource Planning (ERP) systems
Administer data entry into the ERP system
Perform document processing and filing using manual and electronic systems, per established procedures
Monitor change activities approval/implementation and be able to resolve issues of varying complexity
Interface with internal and external customers to convey requirements and resolve issues to drive efficient and effective process
Meet Service Level Agreements (SLAs) for change activity processing and implementation
Prioritize and coordinate tasks and projects within a fast-paced and technical business environment
Ensure standard practices and procedures are followed when analyzing data and content
Create, edit, and maintain procedural documentation including, but not limited to, department policies, procedures, and guidance documentation in the corporate quality system
Support record repository management, as needed
Escalate issues and risks to management, as appropriate
Deliver training, as needed
Participate in global business projects supporting corporate initiatives, as requested

Document Control Specialist Resume Examples & Samples

Review and analyze engineering changes per established rules, workflows, approval requirements, BOM compliance, and lifecycle management
Provide backup to all team members through maintaining a working knowledge of all jobs within the department
Establishes and implements changes and enhancements to processes and PLM system
Participates in and leads special projects as assigned
Expert level working knowledge of PLM systems; Agile Administrator preferred
Excellent working knowledge of document control processes, change management and standard practices
Working knowledge of Good Documentation Practices
Knowledge of FDA regulations and regulatory requirements
Ability to operate efficiently and effectively in a fast-paced environment
Knowledge of and ability to work within a global corporate environment is required. Highly collaborative
Ability to communicate at all levels of an organization effectively
Procedural or Technical writing experience preferred

Senior Document Control Specialist Resume Examples & Samples

Will assist in the entry and maintenance of all product documentation, as well as, ensure timely, thorough, and accurate release of Change Orders (CO’s), and Manufacturing Change Orders (MCO’s) processed through Agile and SAP
Ensure processes for maintaining controlled quality system and product documentation in electronic format is well defined to meet Pac Bio’s business management system requirements
Ensure accuracy and integrity of data is maintained in all Document Control databases (Agile/SAP/LMS)
Manages the content on the LMS training database providing additional learning opportunities for employees and creating relevant procedures to support process
Utilizes the LMS to track learning requirements and continuously communicates to departments regarding their training needs and compliance to those needs
Works closely with the Quality department and other functional departments to assign and manage training requirements as it pertains to CO’s
Lead and manage Change Control Board (CCB) meetings as applicable
Will support Document Control customers in achieving targeted product launch schedules
Will provide relevant key performance indicator data as required
Ensure processes for maintaining controlled quality system and product documentation in electronic/hard copy format are well defined to meet company business management system requirements (e.g. drawings, procedures, quality system records, bills of materials, specs, technical literature etc.)
Will assist in performing Agile Product Lifecycle Management (PLM), LMS, and other departmental employee training
Will develop and review procedures, and other quality system documentation to ensure adherence to Good Manufacturing Practice (GMP), ISO 13485 requirement, or other related procedures
Provide administrative/project support related to documentation system requirements

Document Control Specialist Resume Examples & Samples

Working knowledge of Quality System such as 13485 & cGMP requirements
Possesses excellent problem-solving, interpersonal, communication skills
Must be self-motivated, result oriented and work well with minimal supervision
Working knowledge of Microsoft Office products and SAP system

Document Control Specialist Resume Examples & Samples

Act as the Document Control Specialists in support of engineering and product development
Associates’s degree (Bachelor’s degree preferred)
Disciplines preferred, Business Administration, Engineering, Information technology
2 + years’ experience in process, engineering or document management
1 + years’ experience in PLM and ERP systems, preferably PTC Windchill and SAP preferred
Experience working with a diverse Engineering Team
Experience working with Engineering Change Processes
Experience in ERP interfaces and usage
Ability to handle a variety of projects simultaneously
Ability to read, analyze and interpret technical journals and manuals
Ability to respond to common software related inquiries from company employees
Ability to effectively present information to user groups, and/or company employees
Ability to interface with other users in a professional, customer service oriented manner
Ability to advise users of technology options and/ or business processes

Document Control Specialist Resume Examples & Samples

Maintain and continuously improve the Document Control system and processes to ensure compliance with current GMPs
Work with primary originators of documents to ensure that GMP-related SOPs and forms are reviewed, edited, formatted, and approved in a timely manner
Author Quality and GMP related SOPs and forms as assigned, and work with functional departments to ensure accuracy, feasibility and completeness
Provide additional support to the Quality organization as required including maintaining library of original Quality documents, loading PDFs into the Quality Intranet, updating table of contents controlled lists, etc
Document retrieval as needed

Document Control Specialist Resume Examples & Samples

Assure compliance to all Internal Policies and Procedures as well as to all External Standards (QSR, CMDR, ISO 13485 and the MDD)
Perform Change Order/ECO processing and release activities utilizing ERP system
Provide training of DJO Change Order/ECO and Document Control SOPs to personnel throughout the company
Coordinate documentation projects between multi-functional groups at DJ, establishing what the project is, what the requirements are and assist in meeting the requirements and creating and implementing the documents
When needed, create and maintain item master, item branch plant, supplemental and cross-reference data in ERP system
Recommend documentation, drafting and labeling process improvements
Communicate change order information and interface with Manufacturing Engineering, Design Engineering, Production, Purchasing, Quality, Marketing/Sales and Customer Service
Coordinate and maintain part number classifications and databases
Provide documentation assistance with special projects
2-3 years of experience processing change order/ECO requests using an ERP system. Knowledge of basic Documentation Control principles. Familiar with manufacturing, design and marketing disciplines. Strong organizational, project management and communication skills and the ability to perform varied tasks in a disciplined, consistent manner. Must have significant PC experience. Must be able to understand project and business requirements and implement. Must be able to work under minimum supervision and in a team environment. AutoCAD experience preferred but not required

Document Control Specialist Resume Examples & Samples

Prior administrative work experience
Ability to work with team members at all levels
Proficiency with MSOffice products and other software packages, as defined by role

Document Control Specialist Resume Examples & Samples

Contribute to and participate in the implementation of document and change control processes and systems for compliance to applicable medical device QMS and regulatory requirements. This may include the selection, configuration, validation and implementation of an electronic tool or system for document management (eDM) and change control
Support the management of all QMS (e.g. policies, procedures, etc.), production (e.g. batch records) and Regulatory Affairs (e.g. 510(k) compilation and submission to FDA) related documentation and records. This also includes supporting the management of an eDM system
Serve as the QMS documentation SME, providing guidance to colleagues regarding the requirements, adequacy and compliance status of documentation and records related to QMS, production and Regulatory Affairs. This includes the following critical activities
Minimum of three (3) years of working experience in a Document Control or administrative Quality role in a regulated field. Preference given to work experience in medical devices, in-vitro diagnostics, molecular diagnostics or related industries
Working Knowledge of 21CFR Parts 11 and 820, and ISO 13485 QMS
Prior experience utilizing and/or administering an electronic document management system
Prior experience auditing or reviewing Design Control and production records
Prior experience supporting and/or participating in compliance audits or inspections
Action oriented, drives for results and is results oriented
Strong coaching and mentoring skills, include ability to effectively train colleagues within a class-room or workshop setting
Strong and effective communicator (written and verbal)
Motivated and proven ability to work in a team-oriented environment, and a desire to work in a company that places a high value on cooperation and group achievement

Document Control Specialist Resume Examples & Samples

Basic knowledge of office machinery such as copier and scanner
Knowledge of in-house scanning system products, policies and procedures preferred
Good communication and people skills
One (1) year experience working in a business environment required

Document Control Specialist Resume Examples & Samples

Creating Document Change Request forms for reviews and approvals of revised labeling
Creating and maintaining organized file folders for revision history and record retention
Working in Illustrator or In Design to check artwork layers, packaging links, fonts and documents together
Reviewing PDFs to identify a markup is completed and approved before changing
Reviewing updated PDF file against the current version to verify changes are accurate
Review submitted Document Change packets and prepare packet for approval
Review documentation submitted for conformance to requirements
Update Quality System Documents using Word, Excel, Outlook, Adobe and other software tools
Process change control for the release of quality system documentation for distribution to points of use and upon request by customers
Scan, file, and maintain documents
Collaborate with team members to ensure accuracy of written procedures and to reflect actual work processes
Assist with customer audits, regulatory audits and internal audits
Other tasks may be assigned

Document Control Specialist Resume Examples & Samples

Assist the Project Manager, the Construction Manager and the Project Team in all matters relative to project documents and the control and distribution in Prolog Manager
Process project documents and maintain document control files in accordance with project document control procedures. Responsibilities include establish and maintain files, receive, index and scan into Prolog Manager software. Types of project documents include correspondence, field memos, submittals, pay requests, drawing log, safety notices, RFIs, and photos
The control, scanning, indexing, linking and distribution of documents in Prolog. This includes internal and external to project participants distribution of correspondence, technical submittals, project reports, Requests for Information, and contract plans and specifications

Document Control Specialist Resume Examples & Samples

Prepares documentation pertaining to user documentation
Edits and maintains documentation pertaining to user documentation
Files all training and business documentation
Superb customer service skills, including verbal and written communications skills and interpersonal relationship skills, are mandatory
Must be able to interact effectively with upper management
A high school is required, bachelors degree is preferred
Three to Five years general document controls experience
Familiar with Office Suites (Microsoft Word and PowerPoint)

Document Control Specialist Resume Examples & Samples

Handling tasks associated with Document Control, including processing, archival, filing, scanning, indexing and other administrative duties
Prepare documents for archive filing
Index documents for off-site storage
Update excel spreadsheets for tracking
Support customer requests for document in the Archive
2-4- years of clerical work experience, prior experience in Document Control is preferred
Computer skills and knowledge of MS office
Ability to lift up to 50 lbs. and have a strong attention to detail

Senior Document Control Specialist, QMS Resume Examples & Samples

1 Main Accountabilities
Analyze and improve quality processes and documentation through change management to ensure that they meet applicable customer, regulatory and corporate requirements
Assists with all aspects of the change control process, (facilitating CRB meetings, maintain accurate CR log spreadsheet and providing direction on change requests for documentation approval)
Assists with providing metric support to management on change control process so that efficiency as well as compliance is continually improved
Review procedural documentation for completeness of information, compliance to production specifications and compliance to ISO/FDA requirements
Receive and initiate Livelink workflows to review and approve site documentation for accuracy and approval
Monitor, evaluate and report activities and project status from analyzing change request inputs on a weekly basis. Reporting metrics both on a monthly basis and then quarterly for QSMR. Evaluate other tools to make this trending more efficient
Support Validation, DHF, DMR and quality records in terms of record retention and master files both electronic and hard copy
Support the livelink system as a project team member to develop improved process flow
Training advocate for Livelink. Support continuous training throughout the company on Livelink current practices. Assist in training on workflows and e-sign
Livelink support for documentation on permissions, categories and attributes, record management and workflow applications
Assist with internal audits as required
2 Typical Studies-Experience, Skills and Qualifications
1 Studies-Experience
2 Skills and Qualifications
21 CFR Part 820 Quality System Regulation and quality system process knowledge

Document Control Specialist Resume Examples & Samples

High school diploma/GED required. Bachelor’s degree preferred
Medical or Laboratory knowledge preferred
1 to 2 years of experience in a regulated environment and experience in administering document control systems preferred
Understanding of applicable compliance requirements
Goal oriented, with excellent time management and organizational skills
Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization
Keenly attentive to detail
Ability to keep sensitive information confidential
High level of proficiency with PC based software programs

Document Control Specialist Resume Examples & Samples

1-2 years administrative experience
Experience considered in lieu of degree requirements
Background / understanding of documentation Control and Configuration Management is desirable
Knowledge of purchasing contracts, purchase orders, payment terms and delivery terms are helpful
Strong analytical and Information Technology skills with advanced Excel skills required and SAP experience desirable
Capable of multi-tasking to manage multiple tasks and priorities at a fast pace and under tight timelines
Good business sense and negotiation skills
Ability to communicate effectively with external vendors and internal stakeholders
Possess strong organizational and time management abilities
Effective communication and organizational skills
Ability to establish and organize filing and record keeping system
Energetic attitude and ability to see projects through to completion
Team player able to function with minimal supervision

Document Control Specialist Resume Examples & Samples

Creating job books for engineered equipment packages
Collecting, expediting, and organizing technical documents for the engineering department, such as: drawings, parts list, bill of materials, and installation and operation manuals
Reviews the data requirements for each job
Interfaces with customers as required to provide a quality product and good customer service
Review and adapt standard Document Control processes based on customer requirements
Compiles engineering documents following customer requirements and specifications to create Data Packages in a digital format
Submits Data Package documentation to Customers in digital and/or hardcopy format
Creates transmittal letters and electronically transmits required data to customers via e-mail, FTP, or customer specified method
Correctly stores all transmitted documentation within the PDM system
Updates and maintains the Documentation Transmittal Log for all formal customer correspondence
Correctly stores customer comments, red-lines, and special requests in the PDM system, and notifies the appropriate Project Manager upon receipt of customer comments as required
Helps maintain the electronic library of vendor documentation within the PDM system
Helps maintain the accuracy of Documentation Project Tracker
Provides progress and status reports as requested
Makes photocopies of drawings and other documentation
Assist with auditing functions as required
2 years of experience
Excellent Microsoft skills (Office, Word, and Excel)
Must be flexible and adaptable

Document Control Specialist Resume Examples & Samples

Ideal candidate will have experience in an office or similar environment where filing, use of office machines and computer knowledge were required
Experience with MS Office, using Word, Excel, and Outlook
Able to work independently and maintain confidentiality
Ability to communicate both verbally and in written form
Experience with Adobe Acrobat and scanning documents is also preferred

RDC Document Control Specialist Resume Examples & Samples

Work as part of a team ensuring timely delivery of proper documentation and information
Assemble complex technical data books and documentation for customers as required
Create daily, weekly and quarterly reports as needed
Data entry involving specific technical data
Troubleshoot issues or discrepancies
Ensure consistency in record management procedure and policies, which include logging, tracking, retention, retrieval, destruction and disaster recovery
Perform Audits as determined necessary
Identify the areas of concern and make necessary improvements to improve the efficiency of internal processes and procedures to improve MRC standards
Ensure timely information flow between internal and external clients
Take reasonable care for the safety and health of yourself and others; report workplace hazards, injuries, or illness immediately
University degree or High school diploma or a GED (General Education Degree) with 3 years document control experience
Strong organizational skills and ability to prioritize job duties and handle multiple tasks
Ability to establish good rapport with branch employees, department personnel, and other corporate employees using written correspondence, proper phone etiquette, professional interpersonal skills and other effective interpersonal skills
Experience with Microsoft Office products including Excel, Access and Word
A demonstrated exceptionally high level of attention to detail is required
Must have the ability to provide documentation verifying legal work status
Ability to read and speak the English language proficiently in order to communicate with others; to understand and interpret safety instructions; and to respond to inquiries
Ability to understand and comply with MRC guidelines & expectations, to include Code of Conduct and Conflict of Interest guidelines
Must have ability to work in fast paced environment

Document Control Specialist Resume Examples & Samples

Provide a central contact point for all document control issues, support, and ongoing management of the system
Implement the selected document management system solution for both electronic and on site physical copies
Work with (sub) contractors and suppliers to ensure compliance with the Tesla document management system
Collect and manage incoming documents, including but not limited to: submittals, designs, drawings, calculations, and other engineering data, Invoices and progress payments, project correspondence (electronic and hard copies),contracts and procurement information, daily reports, project reports, meeting minutes, pictures and videos, manuals and other software
Publish weekly reports and logs identifying open workflows, mail items, submittals, and other documents
Work with project resources to ensure capture of all relevant project documents
Manage document control support resources for both engineering and construction management
Work with (sub) contractors and suppliers during contract closeout to ensure all project documents are received prior to releasing retention
Evaluate conformance to standards, train and enforce the document control plans
Evaluate long-term storage requirements on systems. Prepare and coordinate project documents register and metadata for seamless transition upon completion of the project
Update and maintain the document control plan in accordance with evaluations, best practices, and Tesla guidance

Document Control Specialist Resume Examples & Samples

The document control clerk utilizes document management systems and is responsible for the accuracy and integrity of business documents throughout the document life cycle
The document life cycle includes filing, archiving, retrieving, purging, and destroying
This position is part of a Project Controls team which is responsible for the organization and efficiency of non-technical aspects of the project
Document control clerks must adhere to the policies, procedures and and legal privacy rules, as they may encounter confidential and sensitive information through the course of their work
Experience working with records management systems is desirable
A document control clerk or specialist must be self-directed and possess a high level of attention to detail and accuracy
He or she must be able to utilize the document control systems and provide consistent and efficient support to many projects
Training will include instruction on file systems, procedures and industry-specific terminology

Tc-document Control Specialist Resume Examples & Samples

BS degree in a related science and 0-2 years experience
Personal care experience a plus
Interpersonal skills with the ability to work in a team oriented environment
Organizational skills and problem solving skills
Oral communication skills to effectively provide feedback to immediate supervisor
Written communication skills for accurate data entry and concise lab reports
Timely execution of multiple project objectives within established timelines
Self-motivated, seeking information from others to accomplish objectives
Ability to display a degree of flexibility regarding changing project priorities
Desire to learn, apply, and enhance skill set while seeking new opportunities
Perform other assignments as delegated by immediate Supervisor
Knowledge with MSOffice Software applications

Document Control Specialist Level Resume Examples & Samples

An experienced professional with a full understanding of area of specialization; resolves wide range of issues in creative ways and effective ways
5 Yrs. Experience with SAP in product data management roles, including bills of material, material masters, drawings, lists
Maintenance and manipulation of document information records in SAP
High level of competency in Microsoft Access and Microsoft Office suite
Ability to create and maintain informational databases and reports using these tools
Experience in bill of materials and product structure
Experience in, or familiarity with, electrical product and electrical product manufacturing. Scope Receives assignments in the form of objectives, inputs and output
Determines the process by which to meet project goals
4 year degree in data management or production operations systems preferred
Frequently interacts with peers and customers to gain cooperation of others or conduct presentations of technical information/project activities
Networks with senior internal/external personnel in own area of expertise

Document Control Specialist Resume Examples & Samples

Managing the process for the creation, review, and approval of documents using docspace electronic document management system
Regular monitoring of approved documents to ensure that all documents which are approved have effective dates assigned to them
Reviewing Change Notifications (CNs) in docspace to ensure the CNs are approved in compliance with docspace requirements, notifying the document owners of the CN status and identifying the next steps to drive the CN to completion
Providing guidance to the ComplianceWire Coordinator to assign the correct training due dates so that the documents become Effective in a flawless and timely fashion
Providing training and assistance for the docspace users and to the other docspace coordinators by guiding/correcting document routes/reviews, creating and tracking Service Support Team tickets
Performing Docspace Business Administrators responsibility such as creating new user accounts, assigning users to Roles and Groups, updating information for existing users, annual review of user’s accounts, and deactivation of user accounts
Responsible for creating the periodic review report to identify documents that are due for periodic review and sending the periodic review report to the appropriate document owners of their site/business unit

Document Control Specialist Level Resume Examples & Samples

Collects and analyzes data to support implementation
Organizes the information into use-able, actionable reports for use by engineering to update products to achieve compliance
Interfaces with several business, operations and engineering services to insure coordination of data across functional lines
Works with a large amount of data that must be organized in an understandable format
Normally receives little instruction on day-to-day work, generally instructions on new assignments
Receives assignments in the form of objectives, inputs and output
5 Yrs., Experience with SAP in product data management roles, including bills of material, material masters, drawings, lists
Experience in, or familiarity with, electrical product and electrical product manufacturing

Document Control Specialist Resume Examples & Samples

Analyze and process Engineering Changes engineering technical documents
Assist Engineering as needed in creating Engineering
Support Engineering Authorized Deviation process as required
Manage the item master information ensuring correct information. Report discrepancies, and coordinate the updating process
Support Design Engineering by monitoring the development activity of initial new releases of product and accompanying technical documents
Participate in the creation and updating of departmental procedures, and publish monthly reports. Create statistical reports and graphs
Provides timely and accurate response on tasks (part number creation, BOM, creation, etc.) to support other departments requiring document control resources
Ensures timely processing and archiving of released documents
Reviews and verifies project documents for completeness and format
BS/BA preferred; or a combination of relevant education plus sufficient experience in a technical environment
Minimum of two years experience in engineering documentation for an electronic manufacturer
Minimum of two years experience within an MRP and/or Demand Flow environment
Proficient in PC use, including Word and Excel in a Windows environment
Strong organizational skills with the ability to analyze and prioritize tasks
Knowledge or experience in engineering, product development, electronics, computer-aided design, quality assurance
Consumer electronics manufacturing experience
Understanding of procurement and material planning processe.s
Ability to read, analyze, interpret, and standardize technical procedures
Ability to use computer programs and tools to develop appropriate and efficient solutions
Ability to write reports, business correspondence, and all operating or training procedures
Ability to effectively present information and respond to questions from managers, engineering staff, and production areas
Ability to input and manipulate SAP data. (Materials, BOM’s, Change Control Numbers, Document Links, etc.)
Experience with PLM systems (preferred PTC, Windchill.)

Document Control Specialist Resume Examples & Samples

Initiate and manage product listings for selected product lines, working closely with product managers, technology, marketing and sales
Follow standardized work practices and procedures, working with product managers marketing, packaging and other product listing resources
Create Packaging bill of materials within the company’s software
Drive continuous process improvements
Minimum 2 years’ experience working in packaging related field
Candidate must be a self-starter
Candidate must show demonstrated ability to work cross-functionally in a detail-oriented work environment
Candidate must have experience with programs or projects with systems/IT content and be comfortable with heavy data entry management
Requires high energy, assertiveness, and self-motivated individual to work in a fast paced environment
Individual must be a self-starter, creative and strategic thinker
Prior Project Management experience

Document Control Specialist Intern Resume Examples & Samples

Experience with MS Office
Experience scanning documents
Database administration experience with proprietary applications (FUSION and/or PaperVision Capture experience preferred)
HS diploma or equivalent, and one year of related experience

Document Control Specialist Resume Examples & Samples

Able to react to change productively and handle other essential tasks as assigned
Complete all research necessary to close tasks for default, foreclosure, and loss mitigation loans
Research various county website for missing documentation
Order and track original documents to and from clients/custodians, and attorneys
Prep and scan custodial documents as required
Process daily file requests for servicing of loans as needed
Process orders and coordinate shipment of files to and from client, custodian and attorney
Prep and scan files or miscellaneous documents related to the servicing of loans
Upload scanned images to FileOnQ as required
Retrieve archived data CDs upon requested
Prepare modification documents as requested
Track and distribute custodial documents as required
Provide weekly updates to team management
Work independently and proficiently, taking ownership of job
A minimum two years experience in banking, real estate and/or mortgage servicing industry; similar clerical roles may be acceptable
Typing, Microsoft Word, Excel, 10-key calculator; knowledge of office equipment and of servicing systems (i.e. LPS), aware of various loan products
Excellent communication skills, both oral and written; ability to work independently; strong analytical, problem solving, research, interpretive and decision making skills; detail oriented; strong leadership, organizational and planning skills; ability to handle multiple priorities and meet deadlines; able to work in a fast-paced environment
Knowledge of Ginnie Mae, Fannie Mae and Freddie Mac document retention guidelines·

Document Control Specialist Resume Examples & Samples

Good knowledge of the drug development process
Excellent written and communication skills and fluency in English
Proficient in Microsoft office applications (including Word, PowerPoint, Excel)
Experience with EDMS
Highly committed to quality
Problem solver
Flexible and persistent
Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks
At least 5 years’ experience preferred

Document Control Specialist Resume Examples & Samples

Administer the Eco’s for the Sensor & Hardware workspaces in Agile
Manages several document control functions: issuance of parts numbers, uploading specification in Agile, providing & maintaining control documents for Operations (TOP/binders), writing ECO’s, uploading standard costs in Agile & Intuitive and minor updates to BOM’s & drawings
Supporting and ensuring Intuitive is properly updated; mainly with approved changes from ECO’s process in Agile
Manage the preparation of Turnover Documentation Packages (mainly large automation projects); ensure the documents are properly approved & reviewed by development
Manage & control of the TruBio Dongle programming
Review processes and analyzing the gaps between documentation and actual execution. Create reports by which these deficiencies will be remedied
Fully comprehend the principles and requirements of Finesse’s QMS
Capable of interpreting company SOPs and policies and applying them in work situations

Document Control Specialist Resume Examples & Samples

Manage content in enterprise wide Quality Document Management Systems such as ISO/TS Quality Procedures, Change Control (ECR/ECN), Product/Process Qualifications, Product/Process Change Notifications (PCN), Customer Document Review, Customer Returns, Customer Specifications, Automotive PPAPs, Data Sheets, external standards
Interfaces with wafer fabrication and assembly/test sites, engineering, and sales to provide technical customer support for process and product qualifications, Production Part Approval Process (PPAP), and reliability assessments of Diodes’ products
Acts as quality representative to external customers, responsible for continually improving the customer's valuation of the quality experienced with any Diodes process, product, or service beginning with new product development through product end-of-life
Support very unique, customer specific inquiries, surveys, and questionnaires from corporate Diodes customers. Complete complex qualification reports meeting very detailed customer specific requirements on very short deadlines
Frequently interacts with customers and Diodes functional managers and engineers in product development, design, test, marketing, sales, planning, manufacturing, etc
Follow up with process stakeholders to assure timely completion of document workflows
Support the Quality organization managing content of different Business Processes. Run and maintain reporting activities
Must be a team player with the ability to interact with other members of Diodes’ regional quality organizations as well as business units and sales teams. Must have a passion for exceeding customer’s expectations as well as company level improvement in Business Processes and Quality Systems Software. Ability to learn and adapt to changes in processes and software tools as many company-wide improvements evolve
Support and perform annual internal quality audits per ISO 9001 and TS16949
Support the ISO/TS Management Representative in preparation for annual Management Review Meetings and ISO/TS audits
Provide general technical support to QRA, Engineering, Marketing and Sales departments as needed
Requires a BS degree in Electrical Engineering with 2-5 years of related experience in the areas of document control, quality systems and/or business process development
Experience in semiconductor manufacturing and qualification processes and reliability procedures highly beneficial
Must be well-organized, self-directed, self-starter, highly motivated, proactive problem solver
Strong communication skills – written and verbal – are needed as well as an ability to work comfortably across organizational boundaries to get results, drive change and influence actions without direct authority
Must be proficient in Microsoft Office Environment, particularly Word, Excel, PowerPoint
Proficiency in Lotus Notes/Domino and Adobe Acrobat Pro would be beneficial
Excellent professional verbal and written communication skills
Able to handle multiple tasks simultaneously in a dynamic environment
Familiarity with JEDEC and AEC-Q100/Q101 as well as ISO 9001, TS16949 standards as well as RoHS, ELV, WEEE, etc…
Hands-on ISO/TS Audit experience is a plus

Document Control Specialist Resume Examples & Samples

Serve as system admin for Configuration Management software
Resolve user issues and manage user access
Modify roles and workflows according to organizational structure changes
Collaborate with 3rd party developers to identify and implement enhancements
Train internal groups on use of software
Maintain NPD/documentation control best practices
1-2 years administrative experience required
Background/understanding of documentation control preferred
Ability to work effectively on teams

Document Control Specialist Resume Examples & Samples

Maintaining and tracking of documents
Document Review Reporting
Scanning in all relevant new documents
Checking that documents are accurate
Presentation and filing of documents and drawings
Responsible for maintaining hard copy information
Issuing and distributing controlled copies of information
Managing and maintaining SharePoint and Convero Document Control System
Provide advice on procedures of issue and methods in accessing the system
Ensuring all documents are as up to date as possible within electronic filing systems
To read, understand and implement the Company Safety Policy and the arrangements described in the Company and area Safety Management System documents
High School or above
Minimum 5 years industrial experience
3 years experience in similar position
Track record of 3 years
Must have handled Document Controls activities for large - size refinery or petrochemical projects of value not less than US $ 500 Million
Strong database and communication skills
Experience with document control packages
Excellent interpersonal skills and a professional telephone manner
Utilizing a range of office software, including email, spreadsheets and databases
A comprehensive understanding of health and safety regulations
Ability to evaluate, prioritize, organize and delegate work schedules
Proven decision making skills
Able to react quickly and effectively when dealing with challenging situations
Assisting departments with queries on documentation requirements & submissions

Document Control Specialist Resume Examples & Samples

Process Quality Management System (QMS) document related activities in all applicable Arthrex’s software
Process Engineering Change Orders (ECO) related activities in all applicable Arthrex’s software
Retain QMS records in accordance with established requirements
Administer QMS related training activities in Arthrex’s applicable software
Provide internal customer guidance and support for all process, document, and record related activities associated with the department
Proactively identify and propose opportunities for improvement in daily workflow
Associates Degree or 3 years of direct experience in Document Control required
Strong interpersonal, oral, and written communication skills required
Experience in Agile, SAP, or any other relevant software preferred
Experience or formal training in technical aspects of Quality Assurance and/or Document/Record Control preferred
Experience in regulated industry preferred
Understanding of ISO, FDA, and other relevant requirements as related to control of documents and records, to ensure compliance with such requirements and efficiency in related business processes
Understanding of Quality Assurance requirements, and engineering fundamentals
Detail-oriented, ability to learn and follow procedures and processes accurately, and ability to work in fast paced environment and handle multiple tasks and requests

Document Control Specialist Resume Examples & Samples

Will follow procedures and processes to accomplish administrative and document control duties
Perform data entry into an electronic document management system
Prepare and maintain project filing system
Assist with receiving, processing and expediting internal and external distribution of engineering and supplier documents

Document Control Specialist Resume Examples & Samples

Reviews and approve Manufacturing and related documentation to support timely product and system release
Conducts internal audit of SOP's, training records, and other document types on an as needed basis
Assists and guides engineering in the preparation of product documentation, product configuration and document change request package development
Assists in providing training on documentation and labeling processes and systems
Create, review and revise documentation procedure according to standard operating procedures
Train staff on document control processes and procedures
Process, distribute, and maintain controlled documentation using a document control system
Process documents for revision and approval
Organize the routing of documents throughout the process from conceptualization, approvals, distribution to filing
Ability to understand drawing and schematics

Document Control Specialist Resume Examples & Samples

Provide support to Business Unit Quality Managers while maintaining Semtech’s Customer Information Request process and related data repositories, and files
Evaluate and respond to customer information requests, determine what is needed, gather the data, complete the request and send to customer within the time constraints defined
Work with suppliers to obtain data necessary to complete requests, populate the data repository (PLM), and keep the customer informed on activities extending beyond their requested date
Establish and maintain cycle times for the customer request system working closely with customers, suppliers, and other quality team members to quickly and efficiently resolve requests for information by using the using supported document repositories and the current quality system, PLM and RoHS Compliance Table to their satisfaction
Maintain and gather product and process data required for periodic reporting as required by customers
Follow up with back end quality processes supporting supplier corrective actions, process-change notifications, non-conforming material requests, end of life notifications and supplier environmental test reports
3 years of prior experience working with environmental matters of RoHS compliance, REACH, HF compliance and associated Hazardous Substances
Proficient with MS Office (emphasis using Excel), Adobe Acrobat and Visio
Effective communicator with the ability to interface at all levels within the organization, possessing a thorough written and verbal command of the English language

Document Control Specialist Resume Examples & Samples

File within our filing system all deals, forms records and reports
Examine incoming material for legibility and classify properly
Retrieve file information as necessary using our “Pull a Deal” system
Keep files current and maintain a record of files removed
Make copies, Email documents as necessary
Proofread for accuracy

Document Control Specialist, Irwindale, CA Resume Examples & Samples

Confers with documents originators or engineering liaison personnel to resolve discrepancies and compiles required changes to documents
Enters engineering data into cPDM
Assists customers in coordinating engineering change orders
Assist in training Change Control Authors with Change Control procedures and requirements
Assist Documentation Supervisor with improvement and standardization of Document Change Control processes
Follows all standard operating procedures
Develop engineering change orders packages
Manage and monitor training quality system elements as needed
Maintains effective change and version control of all documents
Support NDP pipeline projects
Perform other duties assigned as needed
Bachelor’s degree in Physical Science/Engineering or Bachelor’s degree with 3 years of combined experience in related area
Direct experience in Quality Systems within medical device industry is preferred
Experience with a variety of software programs, specifically JD Edwards, PLM systems or labeling software is preferred
Hands-on experience using Microsoft Excel, Outlook and Word
Hands-on experience using Adobe Professional
Knowledge of software system dependencies and data management
Ability to work in fast paced environment and rapidly shift priorities
Ability to quickly adapt and navigate various technology and computer software
Ability to communicate with multiple levels of management

100

Document Control Specialist Resume Examples & Samples

Maintains and established data distribution system and expedites review, signature approval and release of documentation in a timely manner
Analyzed and develops recommendations to improve current processes
Maintaining the Change Control Database
Confers with change originators to prepare documents and change requests. Works with document originators to resolve discrepancies in order to make required changes to the documentation
Actively participates in external and internal audits
Responsible for record retention process
Participates in the creation of new processes to improve Quality System
Manages and maintain active, obsolete, and computerized files which support the documentation system
Minimum Associate’s Degree
Minimum 3 years of experience in Engineering and Documentation Control Systems
Minimum 3 years of experience reading and developing technical drawings/prints
Minimum 3 years of experience in technical writing, coordinating change control processes, document control, and, reporting metrics

101

Document Control Specialist Resume Examples & Samples

Create, implement, and maintain all Engineering and Production changes such as Engineering Change Request (ECR), Document Change Order (DCO), Manufacturing Change Order (MCO), Temporary Waiver (TW) and Engineering Change Order (ECO) using Arena Product Lifecycle Management (PLM) software
Collaborate with the Operations, Engineering, and Product Management teams in preparing documentation packages for new product releases, and documentation related to ECOs including routings andobtaining approvals. Complete in a timely manner including monitoring the change implementation
Maintain a comprehensive document control filing system and related databases, including administering and updating the Product Lifecycle Management (PLM) system and related interface to corresponding data elements in the enterprise resource planning Enterprise Resource Planning (ERP) system
Review documents and document packages for completeness, accuracy, consistency and format, and proper authorizations. Resolve issues as required
Responsible for the development, administration and maintenance of the arena PLM database including routings, approvers, distribution lists, and document capture
Support SOX compliant audits

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