Document Control Specialist

3 weeks ago

Bothell, United States LanceSoft, Inc. Full time

Job Title: Quality Assurance Document Control (QADC) Associate Specialist

Location: Bothell, WA 98021

Duration: 6 Months


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


Top Skills:

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


Job Description:

The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.


Education: Bachelor’s degree or equivalent


Experience Basic Qualifications:

  • Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment
  • Strong communication and customer service skills.
  • Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles
  • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
  • Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement
  • Able to prioritize, manage time well, multi-task, and troubleshoot effectively
  • Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables
  • Possess project management skills.
  • Experience interacting with FDA or other regulatory agencies strongly preferred
  • Strong knowledge of cGMPs and domestic regulatory requirements
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
  • Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network
  • Some labeling experience strongly preferred

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