Document Control Specialist Job Description

Document Control Specialist Job Description

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Document control specialist provides customer service and training to all employees needing assistance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

Document Control Specialist Duties & Responsibilities

To write an effective document control specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included document control specialist job description templates that you can modify and use.

Sample responsibilities for this position include:

Administers document system access and revision control to ensure appropriate security based on business need
Assists with the assessment, acquisition and/or deployment of electronic document management systems
Assists in the development of document classifications to facilitate information storage and retrieval
Assist managers and others in creating training curricula, materials, documentation
Provide additional support to the Quality organization as required including maintaining original Quality documents, loading PDFs into the Quality SharePoint, updating controlled lists
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 extracts list of project materials and provides to engineering
Receive, file, and maintain all GXP documents, including but not limited to standard operating procedures (SOPs), test methods, specifications, incident reports, CAPAs, Product Complaints, computer system validation
Manage a Document Repository that tracks the receipt, revisions and archiving of all GXP documents
Oversee and administer document lifecycle management the Document Change Request process
Assist in the maintenance of training records and documentation within our Learning Management System

Document Control Specialist Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Document Control Specialist

List any licenses or certifications required by the position: ISO, APICS, ASQ, 9001, FDA, CMII, CQA, C&A, LEAN, TSE

Education for Document Control Specialist

Typically a job would require a certain level of education.

Employers hiring for the document control specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Technical, Engineering, Education, Associates, Business, Science, Management, Computer, General Education, Life Sciences

Skills for Document Control Specialist

Desired skills for document control specialist include:

Microsoft Word
Excel
Good Documentation Practices
ISO 13485
Engineering design and manufacturing concepts
Computer applications
Microsoft Office
Outlook
GDP and GMP to daily tasks

Desired experience for document control specialist includes:

Experience in maintaining GXP training records, materials or courses
Experience with an electronic Quality/Document Management System preferred
Good organizational, project management skills and ability to perform varied tasks in a disciplined, consistent manner
Ability to analyze, interpret technical procedures and regulations
Quality Assurance experience in the Pharmaceutical/Biotechnology industry, including the ability to identify and resolve document control and training compliance issues
Problem solver and ability to deal with a variety of concrete variables in situations where only limited standardization exists

Document Control Specialist Examples

1

Document Control Specialist Job Description

Job Description Example
Our innovative and growing company is hiring for a document control specialist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for document control specialist
  • Perform review of documents submitted through the change control process for format, completeness, review and approvals
  • Process document requests to be used in-house or sent to CSPs in a timely manner
  • Provide guidance and training to staff regarding document control processes
  • Other essential duties as assigned
  • Coordinate with and assist company internal departments to effect a timely and accurate preparation of order related documents
  • Process daily inspection reports
  • Coordinate Change Order information processing
  • Process monthly contractor pay estimates and measured quantities
  • Coordinate request for material testing
  • Function as the Document Management System administrator (QM1) for the Rochester site
Qualifications for document control specialist
  • Attention to detail, critical thinker, and effective organization skills required
  • Strong communication and proficient soft skills
  • Must have the ability to multitask, have a strong attention to detail and the ability to work in a fast paced team environment
  • Associates Degree with minimum 5 years of relevant functional experience
  • Ability to sit for long periods of time while doing data entry and validations
  • Experience in Semiconductor/Electronics Industry is a plus
2

Document Control Specialist Job Description

Job Description Example
Our company is growing rapidly and is hiring for a document control specialist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for document control specialist
  • Take notes at department or committee meetings
  • Monitor office supplies and order as needed
  • Develop solutions to improve processes for regulatory submissions
  • Establish and maintain processes for US FDA and global e-submissions
  • Assist with preparation and maintenance of Technical Files and Summary Technical Documents
  • Assist with preparation and maintenance of international submissions database
  • Create, edit and maintain work instructions, process maps and other internal process control documents
  • Interactive collaboration with department management, equipment manufacturer and customer
  • Work with operations team to implement process improvements and revise work instructions to facilitate change in process
  • Participate in quality initiatives such as device analysis and assist with identifying root cause for process issues
Qualifications for document control specialist
  • Bachelor’s degree in engineering, science, or closely related degree preferred
  • Engineering, architectural, and construction documents (i.e., maps, drawings, technical specifications, ) experience is preferred
  • Must be proficient in common software, particularly MS Office
  • 5% to support process improvements and training
  • Additional technical coursework preferred
  • Resource and result oriented attitude
3

Document Control Specialist Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of document control specialist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for document control specialist
  • Run reports on previous like models to gather historical data
  • Verbal and written communication with internal and external customers
  • Performing PDM Coordinator and Implementer tasks
  • Submission review of CNs, assuring correctness and compliance with procedures which support the quality system
  • Completing data entry for routing creation and changes to current routings, material master, and bill of materials (BOM)
  • Advising change request initiators how to put a CN together correctly and responding to other questions and issues relating to PDM and SAP
  • Maintaining metadata integrity
  • Use of Quickbase and Agile
  • Facilitate weekly meetings
  • Management/restructuring all department electronic files including development of a standardized folder structure, file naming convention and conversion of old projects into the new format
Qualifications for document control specialist
  • Knowledge of quality systems and regulatory compliance requirements within pharmaceutical or biotech environment
  • Previous experience with mark up and process change control is a plus
  • Familiar with MS Office and current Windows OS
  • Familiar with software application tools
  • Comfortable learning/using new tools
  • Must have experience using copiers, printers, and scanners
4

Document Control Specialist Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of document control specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for document control specialist
  • Checking the updated PDF file against the current version in EDMS (using compare software or Illustrator)
  • Creating EDMS Change Request folders using guidance from standard templated folder
  • Updating Associated Documents using Word
  • Identify appropriate sequence of testing devices and document the revised process
  • Must be sensitive to time deadlines and ensure that work is accomplished in the time frames required and must be flexible and able to readily adapt to changing priorities
  • Maintain overall document control structure within an electronic document management system
  • Define and maintain user roles and permissions in electronic document management system
  • Devise and ensure the implementation of retention and disposal schedules
  • Resolve electronic document management system problems and issues in collaboration with users, system vendors and IT
  • Administer regulatory notebook and binder documentation system, assigning and numbering notebooks and binders, tracking and archiving
Qualifications for document control specialist
  • Comprehensive knowledge of Document Control standards, practices, and principles
  • Must have experience using a laptop computer vs
  • Must be accustomed to changing priorities
  • Must have a high energy level, be organized, and detailed
  • Job will require walking to several buildings on-site
  • Requires standing for long periods of time (up to 8 hours), filing and digging through boxes to pull data
5

Document Control Specialist Job Description

Job Description Example
Our company is growing rapidly and is hiring for a document control specialist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for document control specialist
  • Complete and submit regulatory licensure and accreditation filings in collaboration with Regulatory management
  • Support development of system and process improvements that would enhance compliance to documentation/training requirements
  • Administer training documentation for regulatory purposes
  • Update BOM from an engineering change notice
  • Manage the item master information ensuring correct information
  • Participate in the creation and updating of departmental procedures, and publish monthly reports
  • Provides timely and accurate response on tasks (part number creation, BOM, creation, ) to support other departments requiring document control resources
  • Oversees all requests for procedural documents related to health authority inspections and internal audits
  • Provides local coverage for responding to urgent requests in a timely manner, retrieving procedural documents from the EDMS
  • Performs technical review of procedural documents, ensuring use of appropriate templates and formatting
Qualifications for document control specialist
  • Knowledge of FDA regulations is a plus
  • Works in normal office environment with controlled lighting and temperatures
  • Repetitive hand/wrist motion related to scanning and indexing
  • AS degree from accredited college with 5 years of overall experience with 2 years specifically in proposal/documentation preparation
  • Minimum of at least 5+ years experience on projects involving Federal funding is required
  • Background in engineering change management

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