Quality Assurance Document Control Associate

3 weeks ago

Bothell, United States Kelly Professional & Industrial Full time

We are hiring a contract Quality Assurance Document Control Associate to support a well-known biotechnology company in Bothell, WA. In this role, you will support the cGMP Document Control operations, 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.


Location: Bothell, WA

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

Duration: 6-12 months (more likely 12)

Pay Rate: $57.33 per hour


Responsibilities:

  • Issuing production batch records, labels, and other controlled documents to support manufacturing operations
  • Responsible for the organization of cGXP controlled document files within the Document Center
  • Assist with managing the Document Center Archive room
  • Managing an electronic document system
  • Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures
  • Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site
  • Support internal and external audits and regulatory inspections.
  • Perform Document Control metric reporting and analysis for the local site data
  • Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders


To be a good fit for this role:

  • Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment
  • Strong communication and customer service skills.
  • Technical writing skill set- 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

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