Education and Training in Pharma
Home » Pharma Blog » What is a Documentation Specialist?

What is a Documentation Specialist?

  • documentation-specialist-entering-data-onto-computer

A documentation specialist is an individual responsible for the writing, distribution, collection, storage, and maintenance of a company’s documentation. In highly regulated industries, these activities are a requirement for regulatory compliance.

Some companies might call this role: Document Controller, Documentation Coordinator

What is Documentation?

Documentation is an extremely important part of many industries. In highly regulated industries – such as pharmaceutical or medical device manufacturing – regulations need to be complied with, but they also need to be shown to be complied with. Documentation (both paper-based and digital) is the way that companies can show that they are complying with the regulations.

Within such highly regulated industries, documentation specialists typically sit as a role within the Quality Department.

Clear and concise documentation is essential for the successful manufacture of safe products. Acting as a stable reference point, they ensure that personnel across all departments and all shifts are following the same protocols – leading to a consistent manufacturing outcome. It also makes sure that actions are recorded with a specific note of times and dates.

As well as tracking routine manufacturing, documentation is also required when issues arise in production. This allows for recording of the problem, what corrective measure were taken and what changes were made to ensure that the problem does not happen again.

What Does a Documentation Specialist do?

A documentation specialist is an individual responsible for the writing, distribution, collection, storage, and maintenance of this documentation.

They can be responsible for implementing new storage systems or working to optimize the efficiency of the system already in place. They must make sure that all documentation is stored securely and can be accessed quickly and accurately at any time.

The specific tasks of any one role might vary but examples of typical tasks carried out by a documentation specialist include:

  • Creates documentation that meets the regulatory requirements before distributing through the company to implement
  • Working closely with colleagues across other departments to ensure that everyone is completing and submitting the necessary documentation
  • Acting as a point of contact for retrieval of specific documentation as required
  • Write, review and update the SOPs relating to documentation collection and storage
  • Keeps up-to-date with the regulatory requirements around documentation and implements changes if necessary
  • Analysis of data submitted via documentation
  • Compilation of reports
  • Deal with long-term storage of information and data protection
  • Participation in internal audits and external regulatory inspections
  • Training of colleagues on the requirements around documentation
  • Revising outdated documents and ensuring that all staff are using the correct version

Becoming a Documentation Specialist

Candidates for these roles will typically have a science-related qualification and some experience within a quality department.

  • Organisational skills – need to ensure that all company employees are provided with (and are using) the most recent version of documentation. As regulatory requirements change, they must be quick and concise in providing updated documents
  • IT skills – there is an increasing number of documents that are kept digitally. Even those still kept on paper will have a digital counterpart or mapping 
  • Written communication skills – when writing new documentation or updates to existing documents, instructions must be clear to all staff. This is essential to ensure that procedures are followed correctly and documents completed accurately
  • Attention to detail – again, to ensure that all staff are clear on what they are required to do, the smallest details of documentation must be clear. Documentation specialists must also be efficient in noticing even the smallest of errors in documentation completion
  • Team working – although many of the tasks require strong independent working skills, the documentation specialist can have a role in coordinating other staff members who contribute to documentation creation, completion or review

What is the Salary of a Documentation Specialist?

For information on average salaries for a documentation specialist, check out our Salaries Page.

Other Articles in This Series

Got More Questions?

Call Geraldine: +1 (617) 901 9268

Call Niki: +353 (0)21 2409013

Post Your Comments Below

This site uses Akismet to reduce spam. Learn how your comment data is processed.