Document Control Specialist Job Description
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:
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:
Desired experience for document control specialist includes:
Document Control Specialist Examples
Document Control Specialist Job Description
- 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
- 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
Document Control Specialist Job Description
- 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
- 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
Document Control Specialist Job Description
- 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
- 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
Document Control Specialist Job Description
- 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
- 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
Document Control Specialist Job Description
- 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
- 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