Document Control Job Description
Document Control Duties & Responsibilities
To write an effective document control job description, begin by listing detailed duties, responsibilities and expectations. We have included document control job description templates that you can modify and use.
Sample responsibilities for this position include:
Document Control Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Document Control
List any licenses or certifications required by the position: ISO, FDA, SQF, PO, MO, APICS, ASQ, 9001, GMO, LEAN
Education for Document Control
Typically a job would require a certain level of education.
Employers hiring for the document control job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Associates, Engineering, Education, Technical, Business, Management, Science, Computer Science, Manufacturing, Business/Administration
Skills for Document Control
Desired skills for document control include:
Desired experience for document control includes:
Document Control Examples
Document Control Job Description
- Understand the documentation and procedural expectations and have a clear understanding of Information Management Policies and Procedures
- Follow company standards, policies and procedures for document control to ensure compliance and audit expectations
- Process all document and drawing changes including administrative clerical checking for accuracy and completeness
- May operate computer terminal to input and retrieve data
- Establish DC support to authors and (local) process owners in defining and producing lean Quality System documents and records
- Processing, distributing, and maintaining controlled documentation using proprietary software, process documents for revision and approval, and monitoring the distribution and reconciliation of all supplier documents
- Flexibility in dealing with several projects and must be responsive to the projects that it serves
- Provides support documentation to meet customer and FDA requirements documentation preparation required for internal, customer, and 3rd party audits
- Document Control Responsibilities for Volcano AtheroMed Quality System-process ECO’s and update documents, and controlled document locations
- Provide ongoing support to the Senior Director, Atherectomy Operations and Senior Management Staff at Menlo Park, provide miscellaneous administrative support to other personnel on an as needed basis
- Familiarity with JAFAN directives
- Experience with databases and has advanced knowledge of the Microsoft suite
- Results and success driven
- Establish/maintain procedures for maintaining documents and change control of documents
- Associates degree and two to five years related experience or 10 years related experience
- Bachelor’s degree in technical discpline
Document Control Job Description
- Manages circulation of documents for management approval
- Manage the updating, filing and distribution of the company quality system documentation
- Maintain and update the Investigation tracking report with new and completed Deviations/Nonconformances, CAPA
- Perform data entry as necessary for the QA and laboratory groups
- Manage updating of procedures and initiating new procedures as needed
- Maintain routine and special reports for quality system data and metrics
- Manage and maintain laboratory notebooks with regards to making, issuing, and archiving
- Maintain and support filing system for various records and other quality system documentation
- Performs other duties as assigned based on business needs as directed by management
- Troubleshoots and analyzes processes and procedures used that ensure compliance with Standard Operating Procedures (SOP)
- Minimum of 5+ years of experience in a biotechnology, biologics, or pharmaceutical GMP facility
- Must be able to multi-task, work in a fast-paced atmosphere, learn quickly, work independently on a team and must be able to work well with employees of all levels
- Assist project leads in the preparation of change orders, notices to proceed, requests for quotation, and other general correspondence
- Assist maintenance of all logs
- Ability to follow detailed directions in a fast-paced environment, taking requests from many people at varying levels of authority
- Interpret OEM and customer product specific documentation to determine relevance to daily responsibilities
Document Control Job Description
- Supports automation of paper-based quality management processes that comply with FDA regulations and that follow ISO 13485 quality standards using tools such as Master Control and/or Oracle Quality Module
- Store, arrange, index and classify controlled records while maintaining on-site access-controlled document storage room and facilitating storage and retrieval of materials with the off-site storage facility
- Supervise direct reports including training
- Provide accurate and timely status reporting metrics of all pertinent document control functions to Engineering and Production department on a regular and continuous basis
- Contribute to and/or participate in continuous process improvement initiatives
- Review Document Control procedures and follow project/customer guidelines
- Organize workload
- Oversee the document control activities for compiling Data Books including verifying documentation for accuracy, completeness, and ensuring all procedures have been fulfilled
- Ensure Data Books are submitted to customers based on customer requirements
- Facilitate and coordinate the management of information flow between client and customers
- Experience with Microsoft Office, Agile, Visio, Adobe Pro, AutoCAD, and / or Labview are preferred but not required
- High school diploma and two years of applicable experience required
- Minimum of 1 year experience in document management systems or with manual systems using electronic document storage
- Minimum of 1year experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries
- Familiarity with FDA regulations and ISO series of quality standards preferred
- Desired three (3) years’ experience with administrative work, quality assurance systems and auditing processes preferred
Document Control Job Description
- Ensures that all documents are technically and mechanically accurate, consistent with internal style guidelines, and consistent with regard to clarity, flow, organization, completeness, accuracy, readability, and/or appropriateness
- Communicates with appropriate departments to ensure changes are well documented and easily understood
- Possesses the ability to analyze and resolve complex problems, making clear recommendations for solutions
- Verifies own work and ensures the correct and timely implementation of all documentation
- Update and maintain Master PRV Register and hard copy files from data received from client personnel from outside sources
- Supports the Document Control team
- Supports Change Control System metrics to allow for monitoring of trends
- Supports maintenance of quality system documents which includes maintenance of Device History and Device Master Records, periodic review of documentation, filing and archiving activities
- Collaborates with different members of the QA department working on special projects and additional assignments as directed by Management
- Supports the internal audit system
- Excellent verbal and written communication skills, able to work well within a consultative team-oriented environment
- One year as office/clerical support with demonstrated typing and filing skills
- Ability to use quality systems software, such as MasterControl, SAP, and Trackwise
- Willingness to work as a team member to promote continuous improvement and meet project deadlines as required
- Must be familiar with GDP (Good Documentation Practices)
- Requires standing, bending, lifting up to 20 pounds
Document Control Job Description
- Review supplier information received through Invivo Procurement to determine the appropriate updates to Invivo 12 NC items in Agile and identify if added information is required before an update in Agile can be processed per RoHS Project Instructions
- Assure proper storage of supplier response record as a controlled document and in accordance to the RoHS project Instructions
- Performs content QC of procedural documents, including proof reading and editing
- Maintains the common glossary, ensuring proper change control and documentation of changes
- Provides support of document management activities related to the Janssen Pharmaceuticals Documentation Council, the Pharm sector Document Council, and cross-sector procedures, as needed
- Performs QC of monthly procedural document data in support of the Pharmacovigilance System Master File (PSMF)
- Assists with assignment and monitoring of work across Quality and Document Control
- Performs other duties and specific projects as assigned by the Quality and Document Control Lead
- Act as the custodian of the engineering change management / configuration control process for all drawings and documents to ensure AS9100 compliance
- Maintains change log, oversees in-process changes through internal concurrence process, ensures jurisdiction and classification verification compliance, Enovia Project Integration & Collaboration, Project Master/Project Change request (EPIC PM / PCR) implementation
- Quality Control background is a plus
- Experience with vendor audits a plus
- Knowledge of construction documents including handling submittals a plus
- Self-motivated thinker when assigned long term tasks
- Experience and proficiency in the project software (Infinitrac) is preferred
- Ability to be flexible and change directions to meet company needs