QA Documentation Specialist

Employment Type

: Full-Time

Industry

: Miscellaneous



Job Title: QA Documentation Specialist 
Location: Frederick, MD
Duration: 6 Months (Contract with high possible ext.)

Description:
  • 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 Preferred.

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