Sr. Specialist, QA, Site Based, Redmond, WA

Role Summary

Senior QA Specialist – Document Control, based in Redmond, WA. This role works cross-functionally to ensure operations comply with cGMP expectations and company SOPs. It involves managing increasingly complex records and tasks and training junior personnel within the assigned QA organization.

Responsibilities

• Issue production batch records, labels, and other documents to support manufacturing operations as scheduled, including delegation of these tasks among QA Associates/Specialists.
• Issue documents and labels to support quality control operations as needed, including delegation of these tasks among QA Associates/Specialists.
• Create and issue logbooks.
• Approve document control related documents in the electronic document management system.
• Serve as primary point of contact and guidance for site functional areas regarding documents and label controls.
• Responsible for reconciliation and archival of controlled documentation.
• Support the development and deployment of document control tools, processes, or services, including updates through change controls or CAPAs.
• Responsible for the management of the document control room and archival of documentation both onsite and offsite.
• Support internal and external client audits and regulatory inspections, including SME responsibilities for document control and the archive room and document retrieval.
• Complete investigation write-ups for document control related deviations in a timely manner.
• Perform routine and ad hoc labeling and issuance metric reporting and analysis for the local site data.
• Occasional on-call document or label support for off-hours operations.

Qualifications

• Minimum of 5 years relevant experience in a biopharmaceutical/pharmaceutical cGMP manufacturing or similar environment.
• Ability to collaborate and communicate cross-functionally.
• Proven attention to detail.

Education

• Bachelor’s degree in biological or engineering science.