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Seattle, Washington, United States American Cybersystems Full timeQuality Assurance Specialist - Document Control**Job Summary:**We are seeking a highly skilled Quality Assurance Specialist - Document Control to join our team at American Cybersystems. As a Quality Assurance Specialist - Document Control, you will play a critical role in ensuring the quality and integrity of our documents and...
Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Specialist - Document Control to join our team at American Cybersystems. As a key member of our quality team, you will be responsible for supporting the cGMP Document Control operations for our Cell Therapy Above-site organization.
Key Responsibilities- Manage an electronic document system for the Cell Therapy Above-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 controlled documents for the site.
- Generate document management system reports for Quality Council metric reporting.
- Support internal and external audits and regulatory inspections if required, assist with document retrieval/organization support during regulatory inspections.
- Provide communication regarding the status of Quality Systems deliverables to customers, management, and stakeholders.
- Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.
- Some technical writing skill set, including the 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.
- 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.).
We offer a competitive pay rate of $32.00 per hour, as well as a comprehensive benefits package, including medical and pharmacy coverage, dental/vision insurance, 401(k), and a health savings account (HSA). If you are a motivated and detail-oriented individual with a passion for quality and document control, we encourage you to apply for this exciting opportunity.
