Job Details

  • Title: QA Documentation Specialist
  • Code: RCI-10158
  • Location: Frederick Maryland (MD) 21704
  • Posted Date: 06/22/2021
  • Duration: 3 Months
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  Job Description

QA Documentation Specialist
Willing to work on a weekend shift as needed.

  • Provides clerical and administrative support related to documentation processes and systems.
  • Pre-approves and routes documents for review and approval in the electronic Document Management System (DMS).
  • Approves Document Change Controls and assigns effective dates to documents.
  • Pre-Releases documents for training and adds documents to curricula in the electronic Learning Management System.
  • Maintains the document archival room.
  • Responsible for filing and maintenance of all controlled documents and records. Ensures files are accurate and easily retrievable.
  • Creates logbooks to be used in production.
  • Scans, verifies and archives documentation and records as needed.
  • Performs general word processing tasks.
  • Checks format and conformance to document templates.
  • Ensure the correct and timely input of database entries.
  • Provides support to clients on the process of documents in the DMS and word processing tasks as needed.
  • Participates in function meetings.
  • Notifies manager of compliance questions and issues.
  • Provides additional support and assistance on tasks and projects as directed by management.
  • BA or Equivalent Experience – Current Good Manufacturing Practices (cGMP) and Pharma Industry Experience.
  • Current Good Manufacturing Practices (cGMP) and Pharma Industry Knowledge and Experience.
  • Issue lot related documentation and labels for manufacturing process.
  • Issue GMP documentation for execution including qualification and test methods
  • Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, Documentum, Veeva or equivalent).