Document Specialist Job Description

Document Specialist Job Description

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Document specialist provides document and word processing support in the preparation of nonclinical submission documents including but not limited to INDs, NDAs, CTD, IBs, and CTAs for submission to health authorities.

Document Specialist Duties & Responsibilities

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

Sample responsibilities for this position include:

Work closely with Regulatory Affairs in modifying global regulatory documentation
Interact with personnel in GQO (Cestas & LCDF) in order to meet project deadlines
Updating QA Database
Batch allocation review
Receiving lot numbers, issue sample request
Working with the lab for release documentation
Updating raw material release database
Control of inventory status
Parent lot release documentation
Preparing all shipping documentation for contract packaging

Document Specialist Qualifications

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

Licensing or Certifications for Document Specialist

List any licenses or certifications required by the position: ISO, CDIS, MRPT, APICS, 9001, FDA, US, MS, CDIP, CCDS

Education for Document Specialist

Typically a job would require a certain level of education.

Employers hiring for the document specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Technical, Education, Associates, Business, Engineering, Medical, English, Science, Writing, Medical Terminology

Skills for Document Specialist

Desired skills for document specialist include:

Word and PowerPoint
Dealership finance and insurance procedures
Outlook
But not limited to: Excel
Document Management Systems
Methods and techniques for performing Land Services activities
Excel
Machine codes to report in the event of equipment failure
Escrow functions

Desired experience for document specialist includes:

Filing quality documents (raw materials, batch records)
Manage the initial and any ongoing negotiations and maintenance of a variety of treasury and prime broker-related agreements
Partner closely with internal and external business leads and advisers on agreement terms and conditions
Coordinate bank/broker on-boarding process inclusive of applications, account openings, document production and confidentiality agreements
Deliver and pick-up projects to/from clients in the Bay Area on foot or by van
Check in UPS, Fed Ex, and USPS mail and express packages

Document Specialist Examples

1

Document Specialist Job Description

Job Description Example
Our company is growing rapidly and is looking for a document specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for document specialist
  • Insert standard tabs or create and insert custom tabs per client instructions
  • Create covers and spines per the client instructions and inserts into clear – view binders
  • Perform uploads and downloads from an ftp site
  • Takes ownership for maintaining Medical Writing project files, eTMFs/TMFs in accordance with relevant regulatory requirements
  • Works with Medical Writers to create and maintain Trial Master File Plan and Index
  • Generate and maintain the eTMF tracker, working with Project Manager, study teams, and applicable business partners for reconciliation of the files as part of the quality control process
  • Proactively maintains documents with the standardized filing structure for study documents
  • Gathering, organizing, scanning and shipping of Medical Writings project documentation as required
  • Perform archiving duties on all paper and electronic media storage
  • Performing documentation quality checks, identifying and following up on quality issues with relevant Medical Writing staff
Qualifications for document specialist
  • With LAW Ipro Proficient or scanning software
  • Proficient With Konica, Canon, Xerox or copy / print devices
  • May require flexibility to adjust start/stop times
  • 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
  • Proficiency in English and Spanish, with the ability to perform document translations between English and Spanish, is preferred
  • Assist department management team with maintaining tracking tools and metric data
2

Document Specialist Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of document specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for document specialist
  • Schedules production in accordance to customer forecast demands
  • Orders materials needed for production of customer orders
  • Manages material inventory
  • Sets up part numbers, bill of materials, assembly routing instructions, engineering standards, date code formats and aging requirements
  • Responsible for data maintenance, updating of system records and reports for Supply Chain and Production
  • Executes invoicing for items produced/shipped and extra services performed
  • Reports all materials activity to customer as required
  • Language Skills- requires ability to read, write and comprehend simple instructions, short correspondence, memos and e-mails the ability to effectively interface with co-workers, suppliers, customers, and other employees in English
  • Reasoning Ability- must have the ability to apply common sense understanding to carryout detailed written and/or oral instructions
  • Generate metrics
Qualifications for document specialist
  • 3+ years of document control experience, with at least two-years supporting an engineering and manufacturing project
  • Previous clerical or document support experience is desired
  • Ability to focus on details for repetitive tasks
  • The ability to perform job functions while seated or standing
  • Flexibility for minor schedule changes
  • Organizational skills and the ability to remain focused and productive
3

Document Specialist Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of document 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 specialist
  • Maintains Excel records of daily production and errors, including amount of time devoted to tasks assigned
  • Files and retrieves documents that allows efficient storage and accessibility for a large number of records
  • Researches requests for items by locating and retrieving files and delivering the documented transaction
  • Maintains confidentiality and security of information
  • Assists in training and development of new Document Control Specialists
  • Working with program management and engineering leads to plan and deliver project documentation in accordance with contract requirements
  • Conduct review of documents with compliance to client or customer file plans and SOPs
  • Review installation construction plans to gather the needed parts and create the Bill of Materials
  • Monitor engineering changes that release or replace site installations and ensure those changes are reflected in the Bill of Materials
  • Mange list of upcoming site installations
Qualifications for document specialist
  • Two (2) or more years working in a manufacturing environment
  • Interested and capable in solving problems and driven to execute
  • Must have time-management, decision- making, planning and organizational skills basic computer skills
  • Must be able to follow written and verbal procedures and instructions
  • Requires less than 5% travel
  • Technical background or work toward a computer or technical degree
4

Document Specialist Job Description

Job Description Example
Our innovative and growing company is hiring for a document 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 specialist
  • Support the management of all QMS
  • Troubleshoots and analyzes processes and procedures used to ensure compliance with Standard Operating Procedures (SOP)
  • Files and retrieves documents that allow for efficient storage and accessibility for a large number of records
  • Coordinate the review and revision of procedures, specifications and forms
  • Assist with preparation, formatting, distribution, routing, and maintenance of SOPs and other version controlled documents
  • Assist with review of data and logs generated by Quality Control, Facilities, Process Development and Manufacturing
  • Review and maintain employee training files
  • Create and maintain various filing systems
  • Update QA logbooks, databases and document manuals
  • Remain cognizant of regulatory compliance requirements, guidelines, and trends
Qualifications for document specialist
  • Two (2) years of college courses, preferred
  • Bachelor degree in administration, economics, other relevant field
  • Knowledge of customs procedures
  • Knowledge of legal documents and the purposes
  • Basic green knowledge to be acquired
  • Problem solving, spider in the web
5

Document Specialist Job Description

Job Description Example
Our innovative and growing company is looking for a document 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 specialist
  • Perform task analysis and use error assessment to identify critical and essential tasks
  • Provide input into risk management activities for assigned projects ensuring risk files are aligned with human factors activity and feedback
  • Manage all human factors (HF) activities associated with HF vendors, including on boarding of HF vendor, generation of study brief, attainment of HF vendor proposals, assignment of HF vendor, providing all relevant materials and documentation, management of HF studies, and generation and approval of associated reports
  • Provide HF study feedback and/or recommended mitigation actions into the project Core Team
  • Provide input and support for generation of assigned device Instructions for Use (IFU), device labelling and packaging
  • Support internal and external audits of HF related aspects of the Quality System
  • Actively participates in meetings of the MLR Review Board with particular attention to the review, assessment, and validation of advertising and promotional materials with respect to established MLR, corporate, and FDA rules, regulations, and guidance documents
  • Review documentary credit terms and conditions in conjunction with sales contracts
  • Constant interaction with Joint Ventures before, during and after loading of containers and/or bulk vessels to ensure proper documentation, including stowage plans, packing lists, statement of facts, surveys
  • Constant interaction with shipping agents and surveyors to obtain required documentation, including bills of lading, draft survey reports, quality reports
Qualifications for document specialist
  • Scan client documents per the instructions provided
  • Spotless background is a requirement to be considered
  • Experience managing documents in a Mailroom style setting is a plus
  • Must be extremely detail-oriented and able to sit for long periods of time
  • Computer skills (alpha numeric/10-Key) is also a plus!
  • Attach your resume and apply! I will reach out to you through email for next steps

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