Main Responsibilities and Required Skills for Document Control Specialist

A Document Control Specialist is responsible for ensuring that documentation files and history records are accurate, current, accessible, and aligned with the company's policies and procedures. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Document Control Specialists.

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Main Responsibilities of Document Control Specialist

The following list describes the typical responsibilities of a Document Control Specialist:

Administer

Administer data entry into the ERP system.
Administer the collection, authorizing, publication, storage and retrieval of documents in Vivaldi.

Assist

Assist Document Control personnel with management and processing of engineering documents.
Assist in project wide compliance with document control procedures.
Assist in related tasks as requested by Document Control Manager.
Assist in the development / review and upkeep of project work plans.
Assist in the preparation, release and control of engineering documentation.
Assist the administrative assistants in the on-call operation of the OC file room.
Assist the quality function by serving as a focal point for information collection and distribution.
Assist with metric compilation as directed.
Assist with progress reporting on the document's status / maintaining KPIs in SharePoint Lists.
Assist with the development of document flow procedures.
Assist with the technical writing for the creation and / or editing of the document content.

Communicate

Communicate with internal and external Customers on a regular basis.

Compile

Compile and assemble documents, reports, manuals, etc..

Complete

Complete document linkage at appropriate time.

Contribute

Contribute to the development of necessary training materials.

Control

Control and track the generation and distribution of electronic data.
Control Electronic Quality Management System users' permissions and access sets.

Coordinate

Coordinate and facilitates the timely processing of Artwork Proofing.
Coordinate and facilitate the Change Control Board for change requests.
Coordinate and participates in Change Control Board meetings.
Coordinate the review and revision of procedures, specifications, parts lists, ECOs, BOM and forms.
Coordinate the review of process documentation at established intervals.
Coordinate translations as required.

Create

Create and change material masters as required.
Create and maintain a database of files in an electronic document management system.
Create and maintain customer bills of material, part numbers, approved vendor lists.
Create and maintain document tracking logs.
Create and maintain lot tracking.
Create business process reference documents.
Create Certifications based on submitted documents.
Create Certifications in the site's Certification System based on submitted documents.
Create FDA-compliant ECO packages for all changes of varying complexity.
Create new work instructions and other documentation required in making Medical Devices.
Create / revised and released Change Order.
Create training relevant to Document Management.
Create / update Engineering Masters per released drawings (as built records).
Create / update Product Baseline Records per released drawings (as designed records).
Create what customers need next.

Draft

Draft documents as requested, given input on content.

Drive

Drive to make a difference.

Ensure

Ensure accuracy and completeness of data.
Ensure all technical documents are collected and electronically filed using SharePoint.
Ensure approved mailing addresses are used and acknowledge receipt of all classified documents.
Ensure company records management and retention policies are followed.
Ensure compliance to the guidelines of the Federal Energy Regulatory Commission (FERC).
Ensure documents within the Quality System are reviewed and updated as needed.
Ensure entries are accurate and complete and consistent with company standards.
Ensure process for EDMS are followed and maintained.
Ensure quality procedures are maintained.
Ensure revisions meet intent.
Ensure standard practices and procedures are followed when analyzing data and content.
Ensure that all documents required for new and existing products are processed in a timely manner.
Ensure that documentation files and history records are accurate and current.
Ensure the use of standardized forms and templates.
Ensure training records are properly filed electronically.

Enter

Enter required data for each completed document review action package.

Escalate

Escalate issues and risks to management, as appropriate.

Establish

Establish and maintain files.

Execute

Execute and maintain compliant, efficient Document Control Management system.

Facilitate

Facilitate training internal and external to the PLDM Department.

File

File and maintain print and electronic documentation, tracking internal and external distribution.

Follow

Follow defined procedures and practices to complete daily work.
Follow record retention procedures and policies.

Format

Format Research protocols and reports intended to support the IND.

Generate

Generate metrics at the required frequency which drive accountability and delivery of targets.

Guide

Guide and assist peers in job function areas as needed.
Guide cross-functional teams in Good Documentation Practices.

Identify

Identify and assist in the resolution of roadblocks preventing the release of change notices.
Identify changes needed for existing documentation and processes to support continuous improvement.
Identify, monitor, coordinate, and document training.

Include

Include inspection of labels for purposes of label reconciliation.

Incorporate

Incorporate changes into the document per released change orders.

Input

Input and retrieve electronic files upon request.

Issue

Issue batch records for use in GxP manufacturing campaigns.
Issue Corrective Action / Preventive Action (CAPA) for systemic issues, complaints, etc..
Issue internal specification and product part numbers.

Lead

Lead applicable ECO activities as described above.
Lead cross-functional ECO activities in order to meet agreed upon deadlines.
Lead Pilot Run activities.

Learn

Learn and provide backup for administration of the Learning Management System.

Load

Load approved documents into the site's Document Management System.

Maintain

Maintain all internal documentation.
Maintain and audit physical records filing systems.
Maintain and validate part number database.
Maintain company documentation in accordance with ISO Standards.
Maintain cooperative, diplomatic working relationships with co-workers, manager, and the public.
Maintain document binders to ensure they contain the latest effective revisions.
Maintain integrity of the folder structures on these sites.
Maintain project document filing system in accordance with established procedures.
Maintain Quality Folder organization with updated scanned records.
Maintain the product and engineering documentation files.
Maintain, validate, and create parts list.

Make

Make additions and edits to these files as appropriate or at the direction of management.
Make available, notify and distribute documents to relevant recipients.

Manage

Manage and Maintain Training Management system.
Manage documents for the origination, revision, obsolescence and periodic review.
Manage employee Training Log to ensure employees are trained on all applicable documents.
Manage internal and / or external documentation requests, distribute documents as necessary.
Manage site's document control / quality system activities using ComplianceQuest (CQ) Software.
Manage the handling, storage, and distribution of Protected Information.
Manage the periodic review process for GxP documentation.

Meet

Meet Service Level Agreements (SLAs) for change activity processing and implementation.

Monitor

Monitor, conduct and maintain employee training as required for quality system compliance.
Monitor to ensure that Preventative Maintenance activities are occurring on schedule.

Participate in

Participate in global business projects supporting corporate initiatives, as requested.

Perform

Perform administrative tasks to maintain the document management system Egnyte and Agile.
Perform and / or support regular audits of document control processes and procedures.
Perform data entry of parts into technical database.
Perform filing and scanning of quality system documentation.
Perform inspections within 1 business day of receipt of material and / or request.
Perform job with accuracy and attention to detail, task-oriented.
Perform other Quality System support activities as necessary.
Perform other related duties as assigned.
Perform periodic audits of documents and records to ensure accuracy.
Perform quality assurance on incoming and outgoing project documents.
Perform special projects as assigned.

Plan

Plan and administer site's Quality Records management policies.

Power

Power user within eQMS software, supporting use throughout organization.

Prepare

Prepare Accountable Media for Destruction.
Prepare and follow up on required QA discrepancy / acceptance reports for distribution.
Prepare and record changes to official documents and confirm changes.
Prepare and scan documents into the electronic database.
Prepare box inventories to archive physical records and drawings.
Prepare for shipment outgoing classified mail.
Prepare labeling packages for approvals.
Prepare, process, log, and file incoming and outgoing project documents in Prolog.
Prepare spreadsheets, presentations, and reports as directed.
Prepare transmittals, distribute documents, and retrieve documents.

Prioritize

Prioritize and coordinate tasks and projects within a fast-paced and technical business environment.

Process

Process and maintain facility and technical records according to department policies and procedures.
Process and tracks client and vendor documentation.
Process change notices in SAP (releasing parts BOMs and production documents).
Process ECNs to control revisions of engineering documents.
Process, file, and maintain calibration and preventative maintenance records.
Process, file, and retrieve records.
Process Training Record and upload to QCBD.
Process various change order types and related activities throughout all lifecycle stages.

Provide

Provide administrative support and training on the Editas eDMS system.
Provide backup to QA Specialist.
Provide direction to a staff of three Program Specialists.
Provide general support for the overall Quality System.
Provide general team project and office support as required.
Provide guidance in trouble-shooting and driving resolution of Document Management issues.
Provide guidance in trouble-shooting and driving resolution of ECR / ECO Management issues.
Provide guidance in trouble-shooting and driving resolution of Material Master issues.
Provide immediate quality support to the manufacturing line to document and address concerns.
Provide instructor led training to the site relevant to Document Management.
Provide support for audits and regulatory agency inspections.
Provide technical and administrative support.
Provide training to teams across Hardware and Operations on the document control process.

Raise

Raise issues and concerns to ensure quality standards are met.

Receive

Receive, index and scan documents.

Recommend

Recommend changes and policies to improve and streamline the documentation process.

Record

Record management system data entry, data scrubbing and maintaining data integrity.

Release

Release and distribution of documentation to various functional areas.
Release or reject materials as appropriate.

Relocation

Relocation assistance could be available for qualified candidates.

Represent

Represent Document Control in project and functional meetings.

Review

Review and approve documents for completeness and format accuracy prior to release.
Review, approve and release Quality System Documents.
Review approved documents for accurate format, signatures, dating and good documentation practices.
Review completed training records for completeness and accuracy.
Review documents for accuracy, completeness, and compliance.
Review equipment log, Tagout / logout, first aid kit inspection and upload to QCBD.
Review FDA-compliant documents and packages for accuracy.
Review of all packages for compliance with client specifications prior to distribution.
Review submitted documents for correct formatting according to site requirements.

Revise

Revise Quality System procedures.

Scan

Scan, image, organize, and maintain documents.
Scan documents, update procedures, and create documents as required, electronic document templates.

Support

Support Calibration System - duties include scanning, filing, updating Equipment Log etc..
Support implementation and management of Training system.
Support in-process and final product release for high volume medical device product.
Support internal and external audits as SME for document, labeling, and training systems.
Support other departments as necessary in their needs for Configuration Management information.
Support quality during audits and visits (i.e., customer, regulatory, registrar, internal).
Support record repository management, as needed.
Support reproduction requests.
Support reviewing of Lot History Record and other documents as required.

Track

Track Document Management and Process Items for the site.
Track Document Management indices for the site and work with departments to ensure compliance.

Train

Train employees on Document management systems.
Train the site on new Document Management criteria as needed.

Understand

Understand document signature strategies.

Update

Update drawing database with revisions.
Update quality procedures.
Update related specification documents as needed that are relevant to Document Management procedures.
Update the documentation records and files.
Update various SharePoint libraries by uploading documents and updating document properties.

Work with

Work as part of the team and collaborate with co-workers and colleagues.
Work on Document Control tasks with minimal supervision when necessary.
Work with cross-functional teams to prepare Engineering Change Requests (ECR).
Work with departmental personnel to develop company-wide policies and procedures.
Work with Quality Systems and all levels of facility personnel to achieve company quality standards.
Work with the Hardware Quality team to identify areas of improvement in the QMS.

Most In-demand Hard Skills

The following list describes the most required technical skills of a Document Control Specialist:

Most In-demand Soft Skills

The following list describes the most required soft skills of a Document Control Specialist:

Written and oral communication skills
Organizational capacity
Attention to detail
Interpersonal skills
Handle matters expeditiously
Maintain a professional and cooperative attitude
Prioritize conflicting needs
Work both independently and under document control manager
Work efficiently in a high stress environment
Analytical ability
Detail-oriented