Senior Quality Assurance Associate

Description

• Execute the Day-to-Day Quality Assurance Tasks to Support Ongoing Manufacturing: - Review and approve executed electronic batch record comments and resolve discrepancies with manufacturing personnel. - Review and approve executed test results, perform review tasks in the laboratory information management system to issue Certificates of Analysis (COAs) as applicable. - Provide quality support for manufacturing operations in the cleanroom. - Be a quality point of contact for process support escalations, troubleshooting, triage and resolution. - Perform routine hands-on QA activities such as intake of incoming patient apheresis and drug product pack-out activities. - Compile, review and approve lot disposition records. - Perform routine raw material disposition and approve raw material specifications. - Perform review and approval of Deviation, Change Control, CAPA, Excursion and Nonconformance record deliverables (as applicable). - Promote a culture of safety and GMP compliance. - Identify opportunities for continuous improvement. - Provide support to complex change controls (as applicable). - Support Process and/or Method Qualification and Validation activities by providing quality review of associated protocols, data and reports. - Perform internal audits (as applicable). - Support operational excellence initiatives.

Requirements

• BS degree with 7+ years experience in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field) - 4-6+ years of experience in GMP biopharmaceutical operations with a minimum of 2+ years in GMP quality - Proficiency using multiple digital GMP platforms - Familiarity with Cellular Therapy manufacturing - Familiarity with Lentiviral Vector manufacturing - Experience in clinical and cGMP manufacturing required. - Experience with electronic quality management systems (e.g. deviations, CAPAs, change management) required. - Ability to work effectively both independently and with a team to set goals, develop sound project plans, monitor progress, and report results. - Excellent communication, emotional intelligence and interpersonal skills. - Motivated and organized critical thinker with solid cross-collaboration and business communication skills. - Fast learner, adaptable, with creative problem-solving skills. - Ability to work efficiently, prioritize workflow, meet deadlines and balance competing - The desire and ability to work in a fast-paced, start-up environment. - Excellent analytical skills and scientific/technical expertise.

Benefits

• Employee Assistance Program
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Bothell,WA. Application Deadline This position is anticipated to close on Dec 19, 2025.
• Short and long-term disability
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• Health Spending Account (HSA)
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Transportation benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance