Quality Assurance Specialist

4 weeks ago

Bothell, Washington, United States Omni Inclusive Full time
Job Title: QA Associate Specialist Document Control

About the Role:

We are seeking a highly skilled Quality Assurance Specialist to support our document control operations at our Bothell site. As a key member of our team, you will be responsible for managing our electronic document system, reviewing and approving document change requests, and troubleshooting documents to ensure they are in an effective state.

Key Responsibilities:

* Manage an electronic document system for the Bothell site, including 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.
* Follow policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
* 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 if required.
* Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.

Requirements:

* Bachelor's degree or equivalent
* 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 ability 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

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