Document Control Specialist

3 weeks ago

Bothell, United States SSi People Full time

Role: Quality Assurance Document Control

Location: Bothell, WA

Contract: 6 Months

Shift- Sunday - Thursday 10:00pm - 6:30am


Top Skills:

  • communication and customer service skills.
  • to prioritize, manage time well, multi-task, and troubleshoot effectively.
  • and Excel experience
  • to provide examples on how they have honed in on attention to detail
  • of SOPs, procedures, edits, and annotations within EDMS experience


Duties And Responsibilities:

  • production batch records, labels, and other controlled documents to support manufacturing operations.
  • for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
  • with managing the Document Center Archive room.
  • an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
  • write and revise document control procedures including participating in the development and roll-out of document control tools.
  • Policies, SOPs and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.

REQUIRED COMPETENCIES: Knowledge, Skills, And Abilities:

  • of 1 year of relevant document control management experience in a cGMP/FDA regulated environment.
  • communication and customer service skills.
  • technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles.
  • computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
  • demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.

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