Astellas Pharma Sr. QA Systems Associate in Seattle, Washington
Universal Cells is now part of Astellas!
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Sr. QA Systems Associate opportunity at their Universal Cells facility in Seattle, WA.
The Sr. Quality Systems Associate will be responsible for the authoring, reviewing and approving Standard Operating Procedures, Batch Records, Forms, Templates, Process Support Documentation & Training Materials. This position will have opportunities to integrate compliance initiatives cross-functionally, provide ownership for internal processes and identify areas for quality improvements.
The position will be responsible for growing technical knowledge and continued understanding of quality operations. Maintains a document management system that is compliant with regulatory, quality and business specific requirements. Provides guidance and advice on approved procedures. Collaborates with cross-functional departments to ensure timely implementation of document change requests. Supervises and trains junior specialists on the Document Systems. Will help integrate corporate document management policy and systems as warranted.
Essential Job Responsibilities:
- Authoring Standard Operating Procedures, Batch Records, Forms/Templates, Process Support Documentation & Training Materials
- Editing documentation for clarity, consistency, organization, and effectiveness
- Working directly with Subject Matter Experts to develop content or provide meaningful feedback to improve structure and flow of documentation
- Providing recommendations and leadership to improve processes.
- Creating and maintaining Quality Assurance programs including training, disposition, investigation and CAPA management and material management.
- Leadership is expected to help bring the site into a "Quality focused" mindset. Specific actions include developing training material, 1:1 coaching and education on compliance requirements, engineering document solutions to reduce risk, creating improved communication mechanisms
- Participating in customer meetings and identifying required potential changes to documentation, taking meeting minutes and communicating to external audiences
- May participate on project teams as assigned
- Bachelor's degree in a technical discipline and at least 5 years or MS with 2+ years of related Quality Assurance experience (GMP/GLP experience preferred)
- Strong oral/written communication skills in English
- Expert editing skills, including a real passion for terminology and an eye for missing details
- Ability to explain and interpret information from internal and external sources
- Ability to think quickly and perform complex tasks independently
- Ability to write in a technical tone
- Must be detail-oriented and ensure polished documentation
- Cross-functional communication skills and positive attitude with customer service focus
- GMP/GLP Manufacturing experience
- Microsoft Office skills (Word, Excel, Visio)
- Familiarity with SharePoint
- Familiarity with Electronic Quality Systems (such as Trackwise, MasterControl or Atlas)
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Quality Assurance/Quality Control